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Migraine nerve stimulation device now available over the counter
The Food and Drug Administration has cleared Cefaly Dual (Cefaly Technology) which was previously available only by prescription.
Most migraines involve the trigeminal nerve, which can be accessed through the skin on the forehead. Cefaly Dual stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.
The device has two settings, ACUTE and PREVENT. In the ACUTE setting, the individual wears the device for 60 minutes at headache onset or during a migraine attack. In the PREVENT setting, the individual wears the device for 20 minutes daily to help prevent future episodes.
At the start of a session, the wearer may feel a slight tingling sensation, which gradually increases and spreads throughout the forehead and the front part of the head. After about 14 minutes, the intensity stabilizes and remains constant until the treatment session is over, according to the company. The device automatically shuts off at the end of each session. It can be used as a stand-alone option or with existing treatment, the company noted.
“For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It is our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half,” Jennifer Trainor McDermott, CEO of Cefaly Technology, said in a news release.
The FDA’s over-the-counter clearance of Cefaly Dual was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device, the company said.
An earlier version of the Cefaly device was approved in the United States in March 2014 to help prevent migraine headache in adults aged 18 or older. The next-generation Cefaly Dual device is “small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB,” the company said.
Last spring, the company announced a buyback program where customers in the United States may return their original device and receive a discount of the purchase of the Cefaly Dual device.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has cleared Cefaly Dual (Cefaly Technology) which was previously available only by prescription.
Most migraines involve the trigeminal nerve, which can be accessed through the skin on the forehead. Cefaly Dual stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.
The device has two settings, ACUTE and PREVENT. In the ACUTE setting, the individual wears the device for 60 minutes at headache onset or during a migraine attack. In the PREVENT setting, the individual wears the device for 20 minutes daily to help prevent future episodes.
At the start of a session, the wearer may feel a slight tingling sensation, which gradually increases and spreads throughout the forehead and the front part of the head. After about 14 minutes, the intensity stabilizes and remains constant until the treatment session is over, according to the company. The device automatically shuts off at the end of each session. It can be used as a stand-alone option or with existing treatment, the company noted.
“For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It is our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half,” Jennifer Trainor McDermott, CEO of Cefaly Technology, said in a news release.
The FDA’s over-the-counter clearance of Cefaly Dual was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device, the company said.
An earlier version of the Cefaly device was approved in the United States in March 2014 to help prevent migraine headache in adults aged 18 or older. The next-generation Cefaly Dual device is “small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB,” the company said.
Last spring, the company announced a buyback program where customers in the United States may return their original device and receive a discount of the purchase of the Cefaly Dual device.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has cleared Cefaly Dual (Cefaly Technology) which was previously available only by prescription.
Most migraines involve the trigeminal nerve, which can be accessed through the skin on the forehead. Cefaly Dual stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.
The device has two settings, ACUTE and PREVENT. In the ACUTE setting, the individual wears the device for 60 minutes at headache onset or during a migraine attack. In the PREVENT setting, the individual wears the device for 20 minutes daily to help prevent future episodes.
At the start of a session, the wearer may feel a slight tingling sensation, which gradually increases and spreads throughout the forehead and the front part of the head. After about 14 minutes, the intensity stabilizes and remains constant until the treatment session is over, according to the company. The device automatically shuts off at the end of each session. It can be used as a stand-alone option or with existing treatment, the company noted.
“For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It is our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half,” Jennifer Trainor McDermott, CEO of Cefaly Technology, said in a news release.
The FDA’s over-the-counter clearance of Cefaly Dual was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device, the company said.
An earlier version of the Cefaly device was approved in the United States in March 2014 to help prevent migraine headache in adults aged 18 or older. The next-generation Cefaly Dual device is “small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB,” the company said.
Last spring, the company announced a buyback program where customers in the United States may return their original device and receive a discount of the purchase of the Cefaly Dual device.
A version of this article originally appeared on Medscape.com.
FDA proposes withdrawing Makena’s approval
Makena should be withdrawn from the market because a postmarketing study did not show clinical benefit, according to a statement released today from the Center for Drug Evaluation and Research at the Food and Drug Administration.
The drug, hydroxyprogesterone caproate injection, was approved in 2011 to reduce the risk of preterm birth in women who with previous spontaneous preterm birth. The FDA approved the medication under an accelerated pathway that required another trial to confirm clinical benefit.
The required postmarketing study “not only failed to demonstrate Makena’s benefit to the neonate, but also failed to substantiate any effect of Makena on the surrogate endpoint of gestational age at delivery that was the basis of the initial approval,” Patrizia Cavazzoni, MD, acting director of the CDER, wrote in a letter to AMAG Pharma USA, which markets Makena. The letter also was sent to other companies developing products that use the drug.
Beyond the lack of efficacy, risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention. “The risk of exposing treated pregnant women to these harms, in addition to false hopes, costs, and additional healthcare utilization outweighs Makena’s unproven benefit,” Dr. Cavazzoni said.
The letter notifies companies about the opportunity for a hearing on the proposed withdrawal of marketing approval. Makena and its generic equivalents will remain on the market until the manufacturers remove the drugs or the FDA commissioner mandates their removal, the CDER said.
The FDA commissioner ultimately will decide whether to withdraw approval of the drug. An FDA panel previously voted to withdraw the drug from the market in October 2019, and the drug has remained in limbo since.
Health care professionals should discuss “Makena’s benefits, risks, and uncertainties with their patients to decide whether to use Makena while a final decision is being made about the drug’s marketing status,” the CDER announcement said.
A version of this article originally appeared on Medscape.com.
Makena should be withdrawn from the market because a postmarketing study did not show clinical benefit, according to a statement released today from the Center for Drug Evaluation and Research at the Food and Drug Administration.
The drug, hydroxyprogesterone caproate injection, was approved in 2011 to reduce the risk of preterm birth in women who with previous spontaneous preterm birth. The FDA approved the medication under an accelerated pathway that required another trial to confirm clinical benefit.
The required postmarketing study “not only failed to demonstrate Makena’s benefit to the neonate, but also failed to substantiate any effect of Makena on the surrogate endpoint of gestational age at delivery that was the basis of the initial approval,” Patrizia Cavazzoni, MD, acting director of the CDER, wrote in a letter to AMAG Pharma USA, which markets Makena. The letter also was sent to other companies developing products that use the drug.
Beyond the lack of efficacy, risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention. “The risk of exposing treated pregnant women to these harms, in addition to false hopes, costs, and additional healthcare utilization outweighs Makena’s unproven benefit,” Dr. Cavazzoni said.
The letter notifies companies about the opportunity for a hearing on the proposed withdrawal of marketing approval. Makena and its generic equivalents will remain on the market until the manufacturers remove the drugs or the FDA commissioner mandates their removal, the CDER said.
The FDA commissioner ultimately will decide whether to withdraw approval of the drug. An FDA panel previously voted to withdraw the drug from the market in October 2019, and the drug has remained in limbo since.
Health care professionals should discuss “Makena’s benefits, risks, and uncertainties with their patients to decide whether to use Makena while a final decision is being made about the drug’s marketing status,” the CDER announcement said.
A version of this article originally appeared on Medscape.com.
Makena should be withdrawn from the market because a postmarketing study did not show clinical benefit, according to a statement released today from the Center for Drug Evaluation and Research at the Food and Drug Administration.
The drug, hydroxyprogesterone caproate injection, was approved in 2011 to reduce the risk of preterm birth in women who with previous spontaneous preterm birth. The FDA approved the medication under an accelerated pathway that required another trial to confirm clinical benefit.
The required postmarketing study “not only failed to demonstrate Makena’s benefit to the neonate, but also failed to substantiate any effect of Makena on the surrogate endpoint of gestational age at delivery that was the basis of the initial approval,” Patrizia Cavazzoni, MD, acting director of the CDER, wrote in a letter to AMAG Pharma USA, which markets Makena. The letter also was sent to other companies developing products that use the drug.
Beyond the lack of efficacy, risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention. “The risk of exposing treated pregnant women to these harms, in addition to false hopes, costs, and additional healthcare utilization outweighs Makena’s unproven benefit,” Dr. Cavazzoni said.
The letter notifies companies about the opportunity for a hearing on the proposed withdrawal of marketing approval. Makena and its generic equivalents will remain on the market until the manufacturers remove the drugs or the FDA commissioner mandates their removal, the CDER said.
The FDA commissioner ultimately will decide whether to withdraw approval of the drug. An FDA panel previously voted to withdraw the drug from the market in October 2019, and the drug has remained in limbo since.
Health care professionals should discuss “Makena’s benefits, risks, and uncertainties with their patients to decide whether to use Makena while a final decision is being made about the drug’s marketing status,” the CDER announcement said.
A version of this article originally appeared on Medscape.com.
FDA posts COVID vaccine guidance amid White House pushback
while medical and trade associations called for a thorough review of any such product before approval.
The FDA took the unusual step of posting background materials much earlier than usual for its planned Oct. 22 advisory committee meeting on potential vaccines for COVID-19. The FDA also on Tuesday afternoon released a new guidance document, expanding on a previous set of recommendations the agency released in June.
In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization (EUA), for a COVID-19 vaccine.
“Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the FDA said in the document.
FDA staff have emphasized the higher bar that drugmakers and regulators face in considering approval of a COVID-19 vaccine.
“Vaccines are complex biological products, and an EUA for a COVID-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the agency staff said in the briefing documents.
The FDA’s briefing document for the Oct. 22 meeting appears to be markedly at odds with the claim Trump made in a video Monday night, in which he told the American public that “vaccines are coming momentarily.”
Trump, who is in a tightly contested presidential race against Democratic candidate Joe Biden, has repeatedly made claims of the potential arrival of COVID vaccines that are at odds with timelines offered with guarded optimism by experts in infectious diseases.
But based on these new guidelines from the FDA, it appears that the White House may now endorse the FDA’s stance, according to a Wall Street Journal report based on “people familiar with the matter.”
The publication reports that the White House, which has yet to officially comment, “endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.”
Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, on Monday night said during a virtual appearance at the twenty-first annual New Yorker Festival that there could be evidence as early as November or December about whether one of the vaccines now in testing will work out. He declared himself to have “cautious optimism” about potential rollout of vaccines as early as late 2020 or early 2021.
Peter Lurie, MD, MPH, who earlier served as the FDA’s associate commissioner for public health strategy and analysis, described the agency’s release of the briefing document as being a positive development.
News organizations, including the New York Times, have reported that the White House had sought to block the FDA from releasing further instructions for companies developing COVID-19 vaccines. The Associated Press on Tuesday said that a senior Trump administration official confirmed that the White House had blocked earlier FDA plans to formally publish the safety guidelines based on the 2-month data requirement, arguing that there was “no clinical or medical reason” for it.
“It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors,” said Dr. Lurie, who is now executive director and president of the Center for Science in the Public Interest.
In a news release, he said the White House had sought to keep the FDA guidance under wraps “so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.”
“Even the pharmaceutical industry has been clamoring for the release of these guidelines. We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later,” Dr. Lurie said. “But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.”
Tuesday also saw a flood of statements in support of FDA officials, including tweets from the chief executive of Pfizer, which is among the leaders in the race to develop a COVID-19 vaccine. Pfizer’s Albert Bourla, DVM, PhD, said that the FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”
The American Medical Association on Tuesday announced a public webinar on Wednesday where its president, Susan R. Bailey, MD, will discuss the COVID-19 vaccine review process with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA. The AMA described this webinar as part of work “to restore trust in science and science-based decision-making among policymakers and the public.”
“To ensure media and the physician community are continuously informed about the federal review process for COVID-19 vaccine candidates, the AMA will host a webinar series to gain fact-based insights from the nation’s highest-ranking subject matter experts working to protect the health of the public,” the organization said in announcing the webinar.
In a statement, leaders of the Association of American Medical Colleges said that the FDA’s Vaccines and Related Biological Products Advisory Committee should evaluate any COVID-19 candidate vaccines prior to the FDA issuing an EUA.
“Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product,” said AAMC chief scientific officer Ross McKinney Jr, MD, and AAMC CEO David J. Skorton, MD, in the statement.
Thomas M. File Jr., MD, president of the Infectious Diseases Society of America, said in a statement that his association again asked the White House to “follow medical and scientific expertise in efforts to combat COVID-19.”
“It is imperative that a vaccine be approved on the basis of FDA’s quality standards and that its safety and efficacy are established before it is authorized,” Dr. File said. “A vaccine that has been approved with speed, rather than safety and efficacy, at the forefront will compound the challenges posed by this pandemic. FDA guidelines for approval that set standards the American people can trust are essential to the success of a vaccine.”
Stephen J. Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement that his association “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”
“To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time,” Mr. Ubl said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”
On Oct. 1, Michelle McMurry-Heath, MD, PhD, president and chief executive of the Biotechnology Innovation Organization, released publicly her letter urging Department of Health & Human Services Secretary Alex Azar to “publicly release all new guidance” related to a COVID-19 vaccine. Such a move would bolster public confidence in the vaccine, she said.
“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” she wrote in the Oct. 1 letter to Azar. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”
This article first appeared on Medscape.com.
while medical and trade associations called for a thorough review of any such product before approval.
The FDA took the unusual step of posting background materials much earlier than usual for its planned Oct. 22 advisory committee meeting on potential vaccines for COVID-19. The FDA also on Tuesday afternoon released a new guidance document, expanding on a previous set of recommendations the agency released in June.
In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization (EUA), for a COVID-19 vaccine.
“Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the FDA said in the document.
FDA staff have emphasized the higher bar that drugmakers and regulators face in considering approval of a COVID-19 vaccine.
“Vaccines are complex biological products, and an EUA for a COVID-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the agency staff said in the briefing documents.
The FDA’s briefing document for the Oct. 22 meeting appears to be markedly at odds with the claim Trump made in a video Monday night, in which he told the American public that “vaccines are coming momentarily.”
Trump, who is in a tightly contested presidential race against Democratic candidate Joe Biden, has repeatedly made claims of the potential arrival of COVID vaccines that are at odds with timelines offered with guarded optimism by experts in infectious diseases.
But based on these new guidelines from the FDA, it appears that the White House may now endorse the FDA’s stance, according to a Wall Street Journal report based on “people familiar with the matter.”
The publication reports that the White House, which has yet to officially comment, “endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.”
Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, on Monday night said during a virtual appearance at the twenty-first annual New Yorker Festival that there could be evidence as early as November or December about whether one of the vaccines now in testing will work out. He declared himself to have “cautious optimism” about potential rollout of vaccines as early as late 2020 or early 2021.
Peter Lurie, MD, MPH, who earlier served as the FDA’s associate commissioner for public health strategy and analysis, described the agency’s release of the briefing document as being a positive development.
News organizations, including the New York Times, have reported that the White House had sought to block the FDA from releasing further instructions for companies developing COVID-19 vaccines. The Associated Press on Tuesday said that a senior Trump administration official confirmed that the White House had blocked earlier FDA plans to formally publish the safety guidelines based on the 2-month data requirement, arguing that there was “no clinical or medical reason” for it.
“It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors,” said Dr. Lurie, who is now executive director and president of the Center for Science in the Public Interest.
In a news release, he said the White House had sought to keep the FDA guidance under wraps “so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.”
“Even the pharmaceutical industry has been clamoring for the release of these guidelines. We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later,” Dr. Lurie said. “But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.”
Tuesday also saw a flood of statements in support of FDA officials, including tweets from the chief executive of Pfizer, which is among the leaders in the race to develop a COVID-19 vaccine. Pfizer’s Albert Bourla, DVM, PhD, said that the FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”
The American Medical Association on Tuesday announced a public webinar on Wednesday where its president, Susan R. Bailey, MD, will discuss the COVID-19 vaccine review process with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA. The AMA described this webinar as part of work “to restore trust in science and science-based decision-making among policymakers and the public.”
“To ensure media and the physician community are continuously informed about the federal review process for COVID-19 vaccine candidates, the AMA will host a webinar series to gain fact-based insights from the nation’s highest-ranking subject matter experts working to protect the health of the public,” the organization said in announcing the webinar.
In a statement, leaders of the Association of American Medical Colleges said that the FDA’s Vaccines and Related Biological Products Advisory Committee should evaluate any COVID-19 candidate vaccines prior to the FDA issuing an EUA.
“Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product,” said AAMC chief scientific officer Ross McKinney Jr, MD, and AAMC CEO David J. Skorton, MD, in the statement.
Thomas M. File Jr., MD, president of the Infectious Diseases Society of America, said in a statement that his association again asked the White House to “follow medical and scientific expertise in efforts to combat COVID-19.”
“It is imperative that a vaccine be approved on the basis of FDA’s quality standards and that its safety and efficacy are established before it is authorized,” Dr. File said. “A vaccine that has been approved with speed, rather than safety and efficacy, at the forefront will compound the challenges posed by this pandemic. FDA guidelines for approval that set standards the American people can trust are essential to the success of a vaccine.”
Stephen J. Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement that his association “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”
“To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time,” Mr. Ubl said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”
On Oct. 1, Michelle McMurry-Heath, MD, PhD, president and chief executive of the Biotechnology Innovation Organization, released publicly her letter urging Department of Health & Human Services Secretary Alex Azar to “publicly release all new guidance” related to a COVID-19 vaccine. Such a move would bolster public confidence in the vaccine, she said.
“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” she wrote in the Oct. 1 letter to Azar. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”
This article first appeared on Medscape.com.
while medical and trade associations called for a thorough review of any such product before approval.
The FDA took the unusual step of posting background materials much earlier than usual for its planned Oct. 22 advisory committee meeting on potential vaccines for COVID-19. The FDA also on Tuesday afternoon released a new guidance document, expanding on a previous set of recommendations the agency released in June.
In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization (EUA), for a COVID-19 vaccine.
“Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the FDA said in the document.
FDA staff have emphasized the higher bar that drugmakers and regulators face in considering approval of a COVID-19 vaccine.
“Vaccines are complex biological products, and an EUA for a COVID-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the agency staff said in the briefing documents.
The FDA’s briefing document for the Oct. 22 meeting appears to be markedly at odds with the claim Trump made in a video Monday night, in which he told the American public that “vaccines are coming momentarily.”
Trump, who is in a tightly contested presidential race against Democratic candidate Joe Biden, has repeatedly made claims of the potential arrival of COVID vaccines that are at odds with timelines offered with guarded optimism by experts in infectious diseases.
But based on these new guidelines from the FDA, it appears that the White House may now endorse the FDA’s stance, according to a Wall Street Journal report based on “people familiar with the matter.”
The publication reports that the White House, which has yet to officially comment, “endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.”
Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, on Monday night said during a virtual appearance at the twenty-first annual New Yorker Festival that there could be evidence as early as November or December about whether one of the vaccines now in testing will work out. He declared himself to have “cautious optimism” about potential rollout of vaccines as early as late 2020 or early 2021.
Peter Lurie, MD, MPH, who earlier served as the FDA’s associate commissioner for public health strategy and analysis, described the agency’s release of the briefing document as being a positive development.
News organizations, including the New York Times, have reported that the White House had sought to block the FDA from releasing further instructions for companies developing COVID-19 vaccines. The Associated Press on Tuesday said that a senior Trump administration official confirmed that the White House had blocked earlier FDA plans to formally publish the safety guidelines based on the 2-month data requirement, arguing that there was “no clinical or medical reason” for it.
“It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors,” said Dr. Lurie, who is now executive director and president of the Center for Science in the Public Interest.
In a news release, he said the White House had sought to keep the FDA guidance under wraps “so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.”
“Even the pharmaceutical industry has been clamoring for the release of these guidelines. We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later,” Dr. Lurie said. “But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.”
Tuesday also saw a flood of statements in support of FDA officials, including tweets from the chief executive of Pfizer, which is among the leaders in the race to develop a COVID-19 vaccine. Pfizer’s Albert Bourla, DVM, PhD, said that the FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”
The American Medical Association on Tuesday announced a public webinar on Wednesday where its president, Susan R. Bailey, MD, will discuss the COVID-19 vaccine review process with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA. The AMA described this webinar as part of work “to restore trust in science and science-based decision-making among policymakers and the public.”
“To ensure media and the physician community are continuously informed about the federal review process for COVID-19 vaccine candidates, the AMA will host a webinar series to gain fact-based insights from the nation’s highest-ranking subject matter experts working to protect the health of the public,” the organization said in announcing the webinar.
In a statement, leaders of the Association of American Medical Colleges said that the FDA’s Vaccines and Related Biological Products Advisory Committee should evaluate any COVID-19 candidate vaccines prior to the FDA issuing an EUA.
“Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product,” said AAMC chief scientific officer Ross McKinney Jr, MD, and AAMC CEO David J. Skorton, MD, in the statement.
Thomas M. File Jr., MD, president of the Infectious Diseases Society of America, said in a statement that his association again asked the White House to “follow medical and scientific expertise in efforts to combat COVID-19.”
“It is imperative that a vaccine be approved on the basis of FDA’s quality standards and that its safety and efficacy are established before it is authorized,” Dr. File said. “A vaccine that has been approved with speed, rather than safety and efficacy, at the forefront will compound the challenges posed by this pandemic. FDA guidelines for approval that set standards the American people can trust are essential to the success of a vaccine.”
Stephen J. Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement that his association “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”
“To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time,” Mr. Ubl said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”
On Oct. 1, Michelle McMurry-Heath, MD, PhD, president and chief executive of the Biotechnology Innovation Organization, released publicly her letter urging Department of Health & Human Services Secretary Alex Azar to “publicly release all new guidance” related to a COVID-19 vaccine. Such a move would bolster public confidence in the vaccine, she said.
“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” she wrote in the Oct. 1 letter to Azar. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”
This article first appeared on Medscape.com.
CDC flips, acknowledges aerosol spread of COVID-19
The information reiterates, however, that “COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others.”
In a statement to the media, the CDC said, “Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19–positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles.”
“This is HUGE and been long delayed. But glad it’s now CDC official,” tweeted Eric Feigl-Ding, MD, an epidemiologist and health economist at Harvard University, Boston on Oct. 5.
The CDC announcement follows an abrupt flip-flop on information last month surrounding the aerosol spread of the virus.
Information deleted from website last month
On September 18, the CDC had added to its existing guidance that the virus is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection.”
The CDC then deleted that guidance on Sept. 21, saying it was a draft update released in error.
A key element of the now-deleted guidance said, “this is thought to be the main way the virus spreads.”
The information updated today reverses the now-deleted guidance and says aerosol transmission is not the main way the virus spreads.
It states that people who are within 6 feet of a person with COVID-19 or have direct contact with that person have the greatest risk of infection.
The CDC reiterated in the statement to the media today, “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often, and staying home when sick.”
Among the journals that have published evidence on aerosol spread is Clinical Infectious Diseases, which, on July 6, published the paper, “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors wrote, “there is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).”
Aerosols and airborne transmission “are the only way to explain super-spreader events we are seeing,” said Kimberly Prather, PhD, an atmospheric chemist at the University of California at San Diego, in an interview Oct. 5 with the Washington Post.
Dr. Prather added that, once aerosolization is acknowledged, this becomes a “fixable” problem through proper ventilation.
“Wear masks at all times indoors when others are present,” Dr. Prather said. But when inside, she said, there’s no such thing as a completely safe social distance.
This article first appeared on Medscape.com.
The information reiterates, however, that “COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others.”
In a statement to the media, the CDC said, “Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19–positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles.”
“This is HUGE and been long delayed. But glad it’s now CDC official,” tweeted Eric Feigl-Ding, MD, an epidemiologist and health economist at Harvard University, Boston on Oct. 5.
The CDC announcement follows an abrupt flip-flop on information last month surrounding the aerosol spread of the virus.
Information deleted from website last month
On September 18, the CDC had added to its existing guidance that the virus is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection.”
The CDC then deleted that guidance on Sept. 21, saying it was a draft update released in error.
A key element of the now-deleted guidance said, “this is thought to be the main way the virus spreads.”
The information updated today reverses the now-deleted guidance and says aerosol transmission is not the main way the virus spreads.
It states that people who are within 6 feet of a person with COVID-19 or have direct contact with that person have the greatest risk of infection.
The CDC reiterated in the statement to the media today, “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often, and staying home when sick.”
Among the journals that have published evidence on aerosol spread is Clinical Infectious Diseases, which, on July 6, published the paper, “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors wrote, “there is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).”
Aerosols and airborne transmission “are the only way to explain super-spreader events we are seeing,” said Kimberly Prather, PhD, an atmospheric chemist at the University of California at San Diego, in an interview Oct. 5 with the Washington Post.
Dr. Prather added that, once aerosolization is acknowledged, this becomes a “fixable” problem through proper ventilation.
“Wear masks at all times indoors when others are present,” Dr. Prather said. But when inside, she said, there’s no such thing as a completely safe social distance.
This article first appeared on Medscape.com.
The information reiterates, however, that “COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others.”
In a statement to the media, the CDC said, “Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19–positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles.”
“This is HUGE and been long delayed. But glad it’s now CDC official,” tweeted Eric Feigl-Ding, MD, an epidemiologist and health economist at Harvard University, Boston on Oct. 5.
The CDC announcement follows an abrupt flip-flop on information last month surrounding the aerosol spread of the virus.
Information deleted from website last month
On September 18, the CDC had added to its existing guidance that the virus is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection.”
The CDC then deleted that guidance on Sept. 21, saying it was a draft update released in error.
A key element of the now-deleted guidance said, “this is thought to be the main way the virus spreads.”
The information updated today reverses the now-deleted guidance and says aerosol transmission is not the main way the virus spreads.
It states that people who are within 6 feet of a person with COVID-19 or have direct contact with that person have the greatest risk of infection.
The CDC reiterated in the statement to the media today, “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often, and staying home when sick.”
Among the journals that have published evidence on aerosol spread is Clinical Infectious Diseases, which, on July 6, published the paper, “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors wrote, “there is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).”
Aerosols and airborne transmission “are the only way to explain super-spreader events we are seeing,” said Kimberly Prather, PhD, an atmospheric chemist at the University of California at San Diego, in an interview Oct. 5 with the Washington Post.
Dr. Prather added that, once aerosolization is acknowledged, this becomes a “fixable” problem through proper ventilation.
“Wear masks at all times indoors when others are present,” Dr. Prather said. But when inside, she said, there’s no such thing as a completely safe social distance.
This article first appeared on Medscape.com.
FDA OKs combination immunotherapy for first-line mesothelioma treatment
This is the first drug regimen to receive regulatory approval for mesothelioma in 16 years and only the second systemic therapy to be approved for this indication.
“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen,” Dr. Pazdur added.
Improved overall survival
The approval is based on efficacy results from the CheckMate 743 trial, which compared immunotherapy with a chemotherapy regimen in a cohort of more than 600 treatment-naive patients (no systemic therapies) with unresectable mesothelioma.
Patients were randomized 1:1 to nivolumab and ipilimumab for up to 2 years (n = 303) or six cycles of combination chemotherapy with cisplatin or carboplatin plus pemetrexed (n = 302).
The study results were initially presented during the presidential symposium of the World Congress on Lung Cancer 2020.
The combined immunotherapy regimen was associated with a 26% improvement in overall survival. At 2 years, 41% of patients in the immunotherapy arm were still alive versus 27% in the chemotherapy group.
Overall, the trial demonstrated a statistically significant improvement in overall survival for patients who received nivolumab plus ipilimumab versus those treated with chemotherapy. Median overall survival was 18.1 months versus 14.1 months (hazard ratio, 0.74; P = .002).
Median progression-free survival per blinded independent central review was 6.8 months in the nivolumab plus ipilimumab arm and 7.2 months in the chemotherapy arm (HR, 1.0). The confirmed overall response rate was 40% versus 43% in the immunotherapy and chemotherapy arms, respectively.
Median response duration was 11.0 months in the nivolumab plus ipilimumab arm and 6.7 months in the chemotherapy arm. At 24 months, 32% of the immunotherapy patients were still experiencing a response, compared with 8% of those in the chemotherapy arm.
The recommended doses for unresectable malignant pleural mesothelioma are nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression or unacceptable toxicity, or up to 2 years in patients without disease progression.
The most common adverse reactions (incidence ≥20%) in patients receiving combination immunotherapy were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus.
New standard of care?
The CheckMate 743 trial “met its primary endpoint of statistically improving overall survival for the experimental arm vs chemotherapy in a prespecified interim analysis,” reported study author Paul Baas, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, at the time of its presentation.
He suggested that combination nivolumab and ipilimumab should therefore “be considered as a new standard of care.”
This article first appeared on Medscape.com.
This is the first drug regimen to receive regulatory approval for mesothelioma in 16 years and only the second systemic therapy to be approved for this indication.
“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen,” Dr. Pazdur added.
Improved overall survival
The approval is based on efficacy results from the CheckMate 743 trial, which compared immunotherapy with a chemotherapy regimen in a cohort of more than 600 treatment-naive patients (no systemic therapies) with unresectable mesothelioma.
Patients were randomized 1:1 to nivolumab and ipilimumab for up to 2 years (n = 303) or six cycles of combination chemotherapy with cisplatin or carboplatin plus pemetrexed (n = 302).
The study results were initially presented during the presidential symposium of the World Congress on Lung Cancer 2020.
The combined immunotherapy regimen was associated with a 26% improvement in overall survival. At 2 years, 41% of patients in the immunotherapy arm were still alive versus 27% in the chemotherapy group.
Overall, the trial demonstrated a statistically significant improvement in overall survival for patients who received nivolumab plus ipilimumab versus those treated with chemotherapy. Median overall survival was 18.1 months versus 14.1 months (hazard ratio, 0.74; P = .002).
Median progression-free survival per blinded independent central review was 6.8 months in the nivolumab plus ipilimumab arm and 7.2 months in the chemotherapy arm (HR, 1.0). The confirmed overall response rate was 40% versus 43% in the immunotherapy and chemotherapy arms, respectively.
Median response duration was 11.0 months in the nivolumab plus ipilimumab arm and 6.7 months in the chemotherapy arm. At 24 months, 32% of the immunotherapy patients were still experiencing a response, compared with 8% of those in the chemotherapy arm.
The recommended doses for unresectable malignant pleural mesothelioma are nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression or unacceptable toxicity, or up to 2 years in patients without disease progression.
The most common adverse reactions (incidence ≥20%) in patients receiving combination immunotherapy were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus.
New standard of care?
The CheckMate 743 trial “met its primary endpoint of statistically improving overall survival for the experimental arm vs chemotherapy in a prespecified interim analysis,” reported study author Paul Baas, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, at the time of its presentation.
He suggested that combination nivolumab and ipilimumab should therefore “be considered as a new standard of care.”
This article first appeared on Medscape.com.
This is the first drug regimen to receive regulatory approval for mesothelioma in 16 years and only the second systemic therapy to be approved for this indication.
“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen,” Dr. Pazdur added.
Improved overall survival
The approval is based on efficacy results from the CheckMate 743 trial, which compared immunotherapy with a chemotherapy regimen in a cohort of more than 600 treatment-naive patients (no systemic therapies) with unresectable mesothelioma.
Patients were randomized 1:1 to nivolumab and ipilimumab for up to 2 years (n = 303) or six cycles of combination chemotherapy with cisplatin or carboplatin plus pemetrexed (n = 302).
The study results were initially presented during the presidential symposium of the World Congress on Lung Cancer 2020.
The combined immunotherapy regimen was associated with a 26% improvement in overall survival. At 2 years, 41% of patients in the immunotherapy arm were still alive versus 27% in the chemotherapy group.
Overall, the trial demonstrated a statistically significant improvement in overall survival for patients who received nivolumab plus ipilimumab versus those treated with chemotherapy. Median overall survival was 18.1 months versus 14.1 months (hazard ratio, 0.74; P = .002).
Median progression-free survival per blinded independent central review was 6.8 months in the nivolumab plus ipilimumab arm and 7.2 months in the chemotherapy arm (HR, 1.0). The confirmed overall response rate was 40% versus 43% in the immunotherapy and chemotherapy arms, respectively.
Median response duration was 11.0 months in the nivolumab plus ipilimumab arm and 6.7 months in the chemotherapy arm. At 24 months, 32% of the immunotherapy patients were still experiencing a response, compared with 8% of those in the chemotherapy arm.
The recommended doses for unresectable malignant pleural mesothelioma are nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression or unacceptable toxicity, or up to 2 years in patients without disease progression.
The most common adverse reactions (incidence ≥20%) in patients receiving combination immunotherapy were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus.
New standard of care?
The CheckMate 743 trial “met its primary endpoint of statistically improving overall survival for the experimental arm vs chemotherapy in a prespecified interim analysis,” reported study author Paul Baas, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, at the time of its presentation.
He suggested that combination nivolumab and ipilimumab should therefore “be considered as a new standard of care.”
This article first appeared on Medscape.com.
Golimumab approval extended to polyarticular-course JIA and juvenile PsA
after the Food and Drug Administration approved the tumor necrosis factor inhibitor for these indications on Sept. 30, according to an announcement from its manufacturer, Janssen.
Results from the open-label, single-arm, multicenter, phase 3, GO-VIVA clinical trial formed the basis for the agency’s approval of IV golimumab. GO-VIVA was conducted in 127 patients aged 2-17 years with JIA with arthritis in five or more joints (despite receiving treatment with methotrexate for at least 2 months) as part of a postmarketing requirement under the Pediatric Research Equity Act after the intravenous formulation of the biologic was approved for adults with rheumatoid arthritis in 2013. It demonstrated that pediatric patients had a level of pharmacokinetic exposure to golimumab that was similar to what was observed in two pivotal phase 3 trials in adults with moderately to severely active RA and active PsA, as well as efficacy that was generally consistent with responses seen in adult patients with RA, the manufacturer said.
Besides RA, intravenous golimumab was previously approved for adults with PsA and ankylosing spondylitis. As opposed to the IV dosing for adults with RA, PsA, and ankylosing spondylitis at 2 mg/kg infused over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter, dosing for pediatric patients with pJIA and PsA is based on body surface area at 80 mg/m2, also given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.
The adverse reactions observed in GO-VIVA were consistent with the established safety profile of intravenous golimumab in adult patients with RA and PsA, according to Janssen.
The full prescribing information for intravenous golimumab can be found on the FDA website.
after the Food and Drug Administration approved the tumor necrosis factor inhibitor for these indications on Sept. 30, according to an announcement from its manufacturer, Janssen.
Results from the open-label, single-arm, multicenter, phase 3, GO-VIVA clinical trial formed the basis for the agency’s approval of IV golimumab. GO-VIVA was conducted in 127 patients aged 2-17 years with JIA with arthritis in five or more joints (despite receiving treatment with methotrexate for at least 2 months) as part of a postmarketing requirement under the Pediatric Research Equity Act after the intravenous formulation of the biologic was approved for adults with rheumatoid arthritis in 2013. It demonstrated that pediatric patients had a level of pharmacokinetic exposure to golimumab that was similar to what was observed in two pivotal phase 3 trials in adults with moderately to severely active RA and active PsA, as well as efficacy that was generally consistent with responses seen in adult patients with RA, the manufacturer said.
Besides RA, intravenous golimumab was previously approved for adults with PsA and ankylosing spondylitis. As opposed to the IV dosing for adults with RA, PsA, and ankylosing spondylitis at 2 mg/kg infused over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter, dosing for pediatric patients with pJIA and PsA is based on body surface area at 80 mg/m2, also given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.
The adverse reactions observed in GO-VIVA were consistent with the established safety profile of intravenous golimumab in adult patients with RA and PsA, according to Janssen.
The full prescribing information for intravenous golimumab can be found on the FDA website.
after the Food and Drug Administration approved the tumor necrosis factor inhibitor for these indications on Sept. 30, according to an announcement from its manufacturer, Janssen.
Results from the open-label, single-arm, multicenter, phase 3, GO-VIVA clinical trial formed the basis for the agency’s approval of IV golimumab. GO-VIVA was conducted in 127 patients aged 2-17 years with JIA with arthritis in five or more joints (despite receiving treatment with methotrexate for at least 2 months) as part of a postmarketing requirement under the Pediatric Research Equity Act after the intravenous formulation of the biologic was approved for adults with rheumatoid arthritis in 2013. It demonstrated that pediatric patients had a level of pharmacokinetic exposure to golimumab that was similar to what was observed in two pivotal phase 3 trials in adults with moderately to severely active RA and active PsA, as well as efficacy that was generally consistent with responses seen in adult patients with RA, the manufacturer said.
Besides RA, intravenous golimumab was previously approved for adults with PsA and ankylosing spondylitis. As opposed to the IV dosing for adults with RA, PsA, and ankylosing spondylitis at 2 mg/kg infused over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter, dosing for pediatric patients with pJIA and PsA is based on body surface area at 80 mg/m2, also given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.
The adverse reactions observed in GO-VIVA were consistent with the established safety profile of intravenous golimumab in adult patients with RA and PsA, according to Janssen.
The full prescribing information for intravenous golimumab can be found on the FDA website.
FDA adds polyarticular-course JIA to approved indications for tofacitinib
The Food and Drug Administration has (pJIA).
The approval, announced Sept. 28 by tofacitinib’s manufacturer, Pfizer, marks the first JAK inhibitor to be approved for the condition in the United States and is the fourth indication to be approved for the drug after approvals in adult patients with moderate to severe rheumatoid arthritis following methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure, and moderate to severe ulcerative colitis after failure on a tumor necrosis factor inhibitor.
The agency based its approval on a phase 3, multinational, randomized, double-blind, controlled withdrawal study that had an 18-week, open-label, run-in phase involving 225 patients who twice daily took either a 5-mg tablet or, in patients under 40 kg, a weight-based lower dose in the form of a 1 mg/mL oral solution, according to the company press release. A total of 173 patients from this phase met JIA American College of Rheumatology 30 response criteria, defined as 30% or greater improvement in three of six JIA core set variables and worsening in no more than one of the core set variables; they were then randomized in part 2 of the study to continue the same dose of tofacitinib or receive placebo until 44 weeks. By the end of this period, 31% who received tofacitinib had a disease flare, compared with 55% on placebo (P = .0007). Disease flare was defined as a 30% or greater worsening in at least three of the six variables of the JIA core set, with no more than one of the remaining JIA core response variables improving by 30% or more after randomization.
The types of adverse drug reactions in patients with pJIA were consistent with those seen in adult rheumatoid arthritis patients, according to Pfizer. Serious adverse drug reactions have most commonly been serious infections that may lead to hospitalization or death, and most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Common adverse drug reactions reported in 2% or more of patients during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis taking tofacitinib at 5 mg twice daily were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.
While the 5-mg tablet formulation is already available, Pfizer said it expects the oral solution to be available by the end of the first quarter in 2021.
Prescribing information can be found on the FDA website.
The Food and Drug Administration has (pJIA).
The approval, announced Sept. 28 by tofacitinib’s manufacturer, Pfizer, marks the first JAK inhibitor to be approved for the condition in the United States and is the fourth indication to be approved for the drug after approvals in adult patients with moderate to severe rheumatoid arthritis following methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure, and moderate to severe ulcerative colitis after failure on a tumor necrosis factor inhibitor.
The agency based its approval on a phase 3, multinational, randomized, double-blind, controlled withdrawal study that had an 18-week, open-label, run-in phase involving 225 patients who twice daily took either a 5-mg tablet or, in patients under 40 kg, a weight-based lower dose in the form of a 1 mg/mL oral solution, according to the company press release. A total of 173 patients from this phase met JIA American College of Rheumatology 30 response criteria, defined as 30% or greater improvement in three of six JIA core set variables and worsening in no more than one of the core set variables; they were then randomized in part 2 of the study to continue the same dose of tofacitinib or receive placebo until 44 weeks. By the end of this period, 31% who received tofacitinib had a disease flare, compared with 55% on placebo (P = .0007). Disease flare was defined as a 30% or greater worsening in at least three of the six variables of the JIA core set, with no more than one of the remaining JIA core response variables improving by 30% or more after randomization.
The types of adverse drug reactions in patients with pJIA were consistent with those seen in adult rheumatoid arthritis patients, according to Pfizer. Serious adverse drug reactions have most commonly been serious infections that may lead to hospitalization or death, and most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Common adverse drug reactions reported in 2% or more of patients during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis taking tofacitinib at 5 mg twice daily were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.
While the 5-mg tablet formulation is already available, Pfizer said it expects the oral solution to be available by the end of the first quarter in 2021.
Prescribing information can be found on the FDA website.
The Food and Drug Administration has (pJIA).
The approval, announced Sept. 28 by tofacitinib’s manufacturer, Pfizer, marks the first JAK inhibitor to be approved for the condition in the United States and is the fourth indication to be approved for the drug after approvals in adult patients with moderate to severe rheumatoid arthritis following methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure, and moderate to severe ulcerative colitis after failure on a tumor necrosis factor inhibitor.
The agency based its approval on a phase 3, multinational, randomized, double-blind, controlled withdrawal study that had an 18-week, open-label, run-in phase involving 225 patients who twice daily took either a 5-mg tablet or, in patients under 40 kg, a weight-based lower dose in the form of a 1 mg/mL oral solution, according to the company press release. A total of 173 patients from this phase met JIA American College of Rheumatology 30 response criteria, defined as 30% or greater improvement in three of six JIA core set variables and worsening in no more than one of the core set variables; they were then randomized in part 2 of the study to continue the same dose of tofacitinib or receive placebo until 44 weeks. By the end of this period, 31% who received tofacitinib had a disease flare, compared with 55% on placebo (P = .0007). Disease flare was defined as a 30% or greater worsening in at least three of the six variables of the JIA core set, with no more than one of the remaining JIA core response variables improving by 30% or more after randomization.
The types of adverse drug reactions in patients with pJIA were consistent with those seen in adult rheumatoid arthritis patients, according to Pfizer. Serious adverse drug reactions have most commonly been serious infections that may lead to hospitalization or death, and most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Common adverse drug reactions reported in 2% or more of patients during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis taking tofacitinib at 5 mg twice daily were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.
While the 5-mg tablet formulation is already available, Pfizer said it expects the oral solution to be available by the end of the first quarter in 2021.
Prescribing information can be found on the FDA website.
FDA orders stronger warnings on benzodiazepines
The Food and Drug Administration wants updated boxed warnings on benzodiazepines to reflect the “serious” risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with these medications.
“The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately,” the FDA said in a safety communication.
The FDA also wants revisions to the patient medication guides for benzodiazepines to help educate patients and caregivers about these risks.
“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol, and illicit drugs,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that, while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction, and dependence,” said Dr. Hahn.
Ninety-two million prescriptions in 2019
Benzodiazepines are widely used to treat anxiety, insomnia, seizures, and other conditions, often for extended periods of time.
According to the FDA, in 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies, most commonly alprazolam, clonazepam, and lorazepam.
Data from 2018 show that roughly 5.4 million people in the United States 12 years and older abused or misused benzodiazepines in the previous year.
Although the precise risk of benzodiazepine addiction remains unclear, population data “clearly indicate that both primary benzodiazepine use disorders and polysubstance addiction involving benzodiazepines do occur,” the FDA said.
Data from the National Survey on Drug Use and Health from 2015-2016 suggest that half million community-dwelling U.S. adults were estimated to have a benzodiazepine use disorder.
Jump in overdose deaths
Overdose deaths involving benzodiazepines jumped from 1,298 in 2010 to 11,537 in 2017 – an increase of more 780%. Most of these deaths involved benzodiazepines taken with prescription opioids.
the FDA said.
The agency urged particular caution when prescribing benzodiazepines with opioids and other central nervous system depressants, which has resulted in serious adverse events including severe respiratory depression and death.
The FDA also says patients and caregivers should be warned about the risks of abuse, misuse, addiction, dependence, and withdrawal with benzodiazepines and the associated signs and symptoms.
Physicians are encouraged to report adverse events involving benzodiazepines or other medicines to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration wants updated boxed warnings on benzodiazepines to reflect the “serious” risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with these medications.
“The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately,” the FDA said in a safety communication.
The FDA also wants revisions to the patient medication guides for benzodiazepines to help educate patients and caregivers about these risks.
“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol, and illicit drugs,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that, while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction, and dependence,” said Dr. Hahn.
Ninety-two million prescriptions in 2019
Benzodiazepines are widely used to treat anxiety, insomnia, seizures, and other conditions, often for extended periods of time.
According to the FDA, in 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies, most commonly alprazolam, clonazepam, and lorazepam.
Data from 2018 show that roughly 5.4 million people in the United States 12 years and older abused or misused benzodiazepines in the previous year.
Although the precise risk of benzodiazepine addiction remains unclear, population data “clearly indicate that both primary benzodiazepine use disorders and polysubstance addiction involving benzodiazepines do occur,” the FDA said.
Data from the National Survey on Drug Use and Health from 2015-2016 suggest that half million community-dwelling U.S. adults were estimated to have a benzodiazepine use disorder.
Jump in overdose deaths
Overdose deaths involving benzodiazepines jumped from 1,298 in 2010 to 11,537 in 2017 – an increase of more 780%. Most of these deaths involved benzodiazepines taken with prescription opioids.
the FDA said.
The agency urged particular caution when prescribing benzodiazepines with opioids and other central nervous system depressants, which has resulted in serious adverse events including severe respiratory depression and death.
The FDA also says patients and caregivers should be warned about the risks of abuse, misuse, addiction, dependence, and withdrawal with benzodiazepines and the associated signs and symptoms.
Physicians are encouraged to report adverse events involving benzodiazepines or other medicines to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration wants updated boxed warnings on benzodiazepines to reflect the “serious” risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with these medications.
“The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately,” the FDA said in a safety communication.
The FDA also wants revisions to the patient medication guides for benzodiazepines to help educate patients and caregivers about these risks.
“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol, and illicit drugs,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that, while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction, and dependence,” said Dr. Hahn.
Ninety-two million prescriptions in 2019
Benzodiazepines are widely used to treat anxiety, insomnia, seizures, and other conditions, often for extended periods of time.
According to the FDA, in 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies, most commonly alprazolam, clonazepam, and lorazepam.
Data from 2018 show that roughly 5.4 million people in the United States 12 years and older abused or misused benzodiazepines in the previous year.
Although the precise risk of benzodiazepine addiction remains unclear, population data “clearly indicate that both primary benzodiazepine use disorders and polysubstance addiction involving benzodiazepines do occur,” the FDA said.
Data from the National Survey on Drug Use and Health from 2015-2016 suggest that half million community-dwelling U.S. adults were estimated to have a benzodiazepine use disorder.
Jump in overdose deaths
Overdose deaths involving benzodiazepines jumped from 1,298 in 2010 to 11,537 in 2017 – an increase of more 780%. Most of these deaths involved benzodiazepines taken with prescription opioids.
the FDA said.
The agency urged particular caution when prescribing benzodiazepines with opioids and other central nervous system depressants, which has resulted in serious adverse events including severe respiratory depression and death.
The FDA also says patients and caregivers should be warned about the risks of abuse, misuse, addiction, dependence, and withdrawal with benzodiazepines and the associated signs and symptoms.
Physicians are encouraged to report adverse events involving benzodiazepines or other medicines to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
CDC adds then retracts aerosols as main COVID-19 mode of transmission
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
Reworked OxyContin fails to cut overall opioid abuse, FDA panel says
The long-awaited postmarketing studies of the abuse-deterrent formulation (ADF) of OxyContin (Perdue Pharma) received mixed reviews from a Food and Drug Administration joint advisory committee.
After a 2-day discussion of new research submitted by Perdue, as well as other relevant published data, most members of the Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees came to the conclusion that the reformulated drug “meaningfully” reduced abuse via intranasal administration and intravenous injection, but not overall opioid abuse or overdose.
The reformulated OxyContin “was the first out of the gate,” and “has the greatest market penetration of any ADF” so “it gives us the greatest opportunity to measure change before and after reformulation,” said committee member Traci C. Green, PhD, MSc, professor and director of the Opioid Policy Research Collaborative at Brandeis University, Waltham, Mass.
The FDA approved the original formulation of OxyContin (oxycodone hydrochloride), a mu-receptor opioid agonist, in December 1995 for the management of pain requiring daily round-the-clock opioid treatment in cases where other treatments were inadequate. It approved an ADF version of the product in April 2010.
The updated formulation incorporates polyethylene oxide, an inactive polymer that makes the tablet harder and more crush resistant. The tablet turns into a gel or glue-like substance when wet.
At the request of the FDA, the company carried out four postmarketing studies, which the FDA also reviewed.
- A National Addictions Vigilance Intervention and Prevention Program study that included 66,897 assessments in patients undergoing evaluation for substance use or entering an opioid addiction program. Results showed a drop in up to 52% of self-reported past 30-day OxyContin injection and snorting versus comparators, including extended-release morphine and immediate-release hydrocodone.
- An analysis of 308,465 calls to U.S. poison centers showing a reduction of up to 28% for calls regarding intentional OxyContin-related exposures immediately following the drug’s reformulation. However, the FDA analysis concluded it is unclear whether the decline was attributable to the drug’s reformulation or co-occurring trends.
- A study of 63,528 individuals entering methadone clinics or treatment programs that showed a reduction of up to 27% in OxyContin abuse versus comparators. There was no information on route of abuse. Here, the FDA analysis determined the results were mixed and didn’t provide compelling evidence.
- A claims-based analysis of patients who were dispensed an opioid (297,836 OxyContin; 659,673 a comparator) that showed no evidence that the updated product affected the rate of fatal and nonfatal opioid overdoses.
During the meeting, committee members heard that opioid use in the United States peaked in 2012, with 260 million prescriptions dispensed, then declined by 41% by 2019. ADFs accounted for only 2% of prescriptions in 2019. They also heard that results of a wide variety of studies and surveys support the conclusion that misuse, abuse, and diversion of OxyContin decreased after it was reformulated.
Ultimately, the joint committee voted 20 to 7 (with 1 abstention) that the reformulated drug reduced nonoral abuse. Most members who voted in favor cited the NAVIPPRO study as a reason for their decision, but few found the strength of the evidence better than moderate.
Meeting chair Sonia Hernandez-Diaz, MD, professor of epidemiology, Harvard School of Public Health, Boston, noted the reduction in abuse may, in part, be a result of the overall reduction in opioid use.
Jon E. Zibbell, PhD, senior public health scientist, behavioral health research division, RTI International, Atlanta, who voted “no,” was disappointed there was not more data.
“We had a bunch of years for this and so many of us could have done some amazing studies” related to how abuse changed post reformulation, he said.
As for overall abuse deterrence, the committee believed the evidence was less compelling. Only two members voted that the reformulated version of the drug reduced overall abuse and only one member voted that the reformulated tablets reduced opioid overdose.
Members generally agreed that all of the studies had limitations, including retrospective designs, confounding, and potential misclassifications. Many noted the challenge of assessing abuse pre- and post reformulation given the evolving situation.
For instance, at the time the reformulated drug was launched, public health initiatives targeting opioid abuse were introduced, more treatment centers were opening, and there was a crackdown on “pill-mill” doctors.
In addition, prescribing and consumption habits were changing. Some doctors may have switched only “at-risk” patients to the reformulated opioid and there may have been “self-selection” among patients – with some potentially opting for another drug such as immediate-release oxycodone.
During the meeting, there was discussion about how to interpret a “meaningful” abuse reduction. However, there was no consensus of a percentage the reduction had to reach in order to be deemed meaningful.
Another issue discussed was the term “abuse deterrent,” which some members believed was stigmatizing and should be changed to crush resistant.
There was also concern that prescribers might consider the ADF a “safe” or less addictive opioid. Michael Sprintz, DO, clinical assistant professor, division of geriatric and palliative medicine, University of Texas Health Science Center, Houston, said ADFs might provide physicians with “a false sense of security.”
Dr. Sprintz, also founder of the Sprintz Center for Pain and Recovery, noted the importance of pain medicine physicians understanding addiction and addiction specialists understanding pain management.
Other committee members voiced concern that the reformulation results in patients switching from intravenous and intranasal abuse to oral abuse. Committed abusers can still swallow multiple pills.
Some members noted that reformulated OxyContin coincided with increased transition to heroin, which is relatively cheap and readily available. However, they recognized that proving causality is difficult.
The committee was reminded that the reformulated drug provides a significant barrier against, but doesn’t altogether eliminate, opioid abuse. With hot water and the right tools, the tablets can still be manipulated.
In addition, the reformulated drug will not solve the U.S. opioid epidemic, which requires a multifaceted approach. The opioid crisis, said Wilson Compton, MD, deputy director at the National Institute on Drug Abuse, has resulted in a “skyrocketing” of deaths linked to “tremendously potent” forms of fentanyl, emerging stimulant use issues, and the possible increase in drug overdoses linked to COVID-19.
A version of this article originally appeared on Medscape.com.
The long-awaited postmarketing studies of the abuse-deterrent formulation (ADF) of OxyContin (Perdue Pharma) received mixed reviews from a Food and Drug Administration joint advisory committee.
After a 2-day discussion of new research submitted by Perdue, as well as other relevant published data, most members of the Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees came to the conclusion that the reformulated drug “meaningfully” reduced abuse via intranasal administration and intravenous injection, but not overall opioid abuse or overdose.
The reformulated OxyContin “was the first out of the gate,” and “has the greatest market penetration of any ADF” so “it gives us the greatest opportunity to measure change before and after reformulation,” said committee member Traci C. Green, PhD, MSc, professor and director of the Opioid Policy Research Collaborative at Brandeis University, Waltham, Mass.
The FDA approved the original formulation of OxyContin (oxycodone hydrochloride), a mu-receptor opioid agonist, in December 1995 for the management of pain requiring daily round-the-clock opioid treatment in cases where other treatments were inadequate. It approved an ADF version of the product in April 2010.
The updated formulation incorporates polyethylene oxide, an inactive polymer that makes the tablet harder and more crush resistant. The tablet turns into a gel or glue-like substance when wet.
At the request of the FDA, the company carried out four postmarketing studies, which the FDA also reviewed.
- A National Addictions Vigilance Intervention and Prevention Program study that included 66,897 assessments in patients undergoing evaluation for substance use or entering an opioid addiction program. Results showed a drop in up to 52% of self-reported past 30-day OxyContin injection and snorting versus comparators, including extended-release morphine and immediate-release hydrocodone.
- An analysis of 308,465 calls to U.S. poison centers showing a reduction of up to 28% for calls regarding intentional OxyContin-related exposures immediately following the drug’s reformulation. However, the FDA analysis concluded it is unclear whether the decline was attributable to the drug’s reformulation or co-occurring trends.
- A study of 63,528 individuals entering methadone clinics or treatment programs that showed a reduction of up to 27% in OxyContin abuse versus comparators. There was no information on route of abuse. Here, the FDA analysis determined the results were mixed and didn’t provide compelling evidence.
- A claims-based analysis of patients who were dispensed an opioid (297,836 OxyContin; 659,673 a comparator) that showed no evidence that the updated product affected the rate of fatal and nonfatal opioid overdoses.
During the meeting, committee members heard that opioid use in the United States peaked in 2012, with 260 million prescriptions dispensed, then declined by 41% by 2019. ADFs accounted for only 2% of prescriptions in 2019. They also heard that results of a wide variety of studies and surveys support the conclusion that misuse, abuse, and diversion of OxyContin decreased after it was reformulated.
Ultimately, the joint committee voted 20 to 7 (with 1 abstention) that the reformulated drug reduced nonoral abuse. Most members who voted in favor cited the NAVIPPRO study as a reason for their decision, but few found the strength of the evidence better than moderate.
Meeting chair Sonia Hernandez-Diaz, MD, professor of epidemiology, Harvard School of Public Health, Boston, noted the reduction in abuse may, in part, be a result of the overall reduction in opioid use.
Jon E. Zibbell, PhD, senior public health scientist, behavioral health research division, RTI International, Atlanta, who voted “no,” was disappointed there was not more data.
“We had a bunch of years for this and so many of us could have done some amazing studies” related to how abuse changed post reformulation, he said.
As for overall abuse deterrence, the committee believed the evidence was less compelling. Only two members voted that the reformulated version of the drug reduced overall abuse and only one member voted that the reformulated tablets reduced opioid overdose.
Members generally agreed that all of the studies had limitations, including retrospective designs, confounding, and potential misclassifications. Many noted the challenge of assessing abuse pre- and post reformulation given the evolving situation.
For instance, at the time the reformulated drug was launched, public health initiatives targeting opioid abuse were introduced, more treatment centers were opening, and there was a crackdown on “pill-mill” doctors.
In addition, prescribing and consumption habits were changing. Some doctors may have switched only “at-risk” patients to the reformulated opioid and there may have been “self-selection” among patients – with some potentially opting for another drug such as immediate-release oxycodone.
During the meeting, there was discussion about how to interpret a “meaningful” abuse reduction. However, there was no consensus of a percentage the reduction had to reach in order to be deemed meaningful.
Another issue discussed was the term “abuse deterrent,” which some members believed was stigmatizing and should be changed to crush resistant.
There was also concern that prescribers might consider the ADF a “safe” or less addictive opioid. Michael Sprintz, DO, clinical assistant professor, division of geriatric and palliative medicine, University of Texas Health Science Center, Houston, said ADFs might provide physicians with “a false sense of security.”
Dr. Sprintz, also founder of the Sprintz Center for Pain and Recovery, noted the importance of pain medicine physicians understanding addiction and addiction specialists understanding pain management.
Other committee members voiced concern that the reformulation results in patients switching from intravenous and intranasal abuse to oral abuse. Committed abusers can still swallow multiple pills.
Some members noted that reformulated OxyContin coincided with increased transition to heroin, which is relatively cheap and readily available. However, they recognized that proving causality is difficult.
The committee was reminded that the reformulated drug provides a significant barrier against, but doesn’t altogether eliminate, opioid abuse. With hot water and the right tools, the tablets can still be manipulated.
In addition, the reformulated drug will not solve the U.S. opioid epidemic, which requires a multifaceted approach. The opioid crisis, said Wilson Compton, MD, deputy director at the National Institute on Drug Abuse, has resulted in a “skyrocketing” of deaths linked to “tremendously potent” forms of fentanyl, emerging stimulant use issues, and the possible increase in drug overdoses linked to COVID-19.
A version of this article originally appeared on Medscape.com.
The long-awaited postmarketing studies of the abuse-deterrent formulation (ADF) of OxyContin (Perdue Pharma) received mixed reviews from a Food and Drug Administration joint advisory committee.
After a 2-day discussion of new research submitted by Perdue, as well as other relevant published data, most members of the Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees came to the conclusion that the reformulated drug “meaningfully” reduced abuse via intranasal administration and intravenous injection, but not overall opioid abuse or overdose.
The reformulated OxyContin “was the first out of the gate,” and “has the greatest market penetration of any ADF” so “it gives us the greatest opportunity to measure change before and after reformulation,” said committee member Traci C. Green, PhD, MSc, professor and director of the Opioid Policy Research Collaborative at Brandeis University, Waltham, Mass.
The FDA approved the original formulation of OxyContin (oxycodone hydrochloride), a mu-receptor opioid agonist, in December 1995 for the management of pain requiring daily round-the-clock opioid treatment in cases where other treatments were inadequate. It approved an ADF version of the product in April 2010.
The updated formulation incorporates polyethylene oxide, an inactive polymer that makes the tablet harder and more crush resistant. The tablet turns into a gel or glue-like substance when wet.
At the request of the FDA, the company carried out four postmarketing studies, which the FDA also reviewed.
- A National Addictions Vigilance Intervention and Prevention Program study that included 66,897 assessments in patients undergoing evaluation for substance use or entering an opioid addiction program. Results showed a drop in up to 52% of self-reported past 30-day OxyContin injection and snorting versus comparators, including extended-release morphine and immediate-release hydrocodone.
- An analysis of 308,465 calls to U.S. poison centers showing a reduction of up to 28% for calls regarding intentional OxyContin-related exposures immediately following the drug’s reformulation. However, the FDA analysis concluded it is unclear whether the decline was attributable to the drug’s reformulation or co-occurring trends.
- A study of 63,528 individuals entering methadone clinics or treatment programs that showed a reduction of up to 27% in OxyContin abuse versus comparators. There was no information on route of abuse. Here, the FDA analysis determined the results were mixed and didn’t provide compelling evidence.
- A claims-based analysis of patients who were dispensed an opioid (297,836 OxyContin; 659,673 a comparator) that showed no evidence that the updated product affected the rate of fatal and nonfatal opioid overdoses.
During the meeting, committee members heard that opioid use in the United States peaked in 2012, with 260 million prescriptions dispensed, then declined by 41% by 2019. ADFs accounted for only 2% of prescriptions in 2019. They also heard that results of a wide variety of studies and surveys support the conclusion that misuse, abuse, and diversion of OxyContin decreased after it was reformulated.
Ultimately, the joint committee voted 20 to 7 (with 1 abstention) that the reformulated drug reduced nonoral abuse. Most members who voted in favor cited the NAVIPPRO study as a reason for their decision, but few found the strength of the evidence better than moderate.
Meeting chair Sonia Hernandez-Diaz, MD, professor of epidemiology, Harvard School of Public Health, Boston, noted the reduction in abuse may, in part, be a result of the overall reduction in opioid use.
Jon E. Zibbell, PhD, senior public health scientist, behavioral health research division, RTI International, Atlanta, who voted “no,” was disappointed there was not more data.
“We had a bunch of years for this and so many of us could have done some amazing studies” related to how abuse changed post reformulation, he said.
As for overall abuse deterrence, the committee believed the evidence was less compelling. Only two members voted that the reformulated version of the drug reduced overall abuse and only one member voted that the reformulated tablets reduced opioid overdose.
Members generally agreed that all of the studies had limitations, including retrospective designs, confounding, and potential misclassifications. Many noted the challenge of assessing abuse pre- and post reformulation given the evolving situation.
For instance, at the time the reformulated drug was launched, public health initiatives targeting opioid abuse were introduced, more treatment centers were opening, and there was a crackdown on “pill-mill” doctors.
In addition, prescribing and consumption habits were changing. Some doctors may have switched only “at-risk” patients to the reformulated opioid and there may have been “self-selection” among patients – with some potentially opting for another drug such as immediate-release oxycodone.
During the meeting, there was discussion about how to interpret a “meaningful” abuse reduction. However, there was no consensus of a percentage the reduction had to reach in order to be deemed meaningful.
Another issue discussed was the term “abuse deterrent,” which some members believed was stigmatizing and should be changed to crush resistant.
There was also concern that prescribers might consider the ADF a “safe” or less addictive opioid. Michael Sprintz, DO, clinical assistant professor, division of geriatric and palliative medicine, University of Texas Health Science Center, Houston, said ADFs might provide physicians with “a false sense of security.”
Dr. Sprintz, also founder of the Sprintz Center for Pain and Recovery, noted the importance of pain medicine physicians understanding addiction and addiction specialists understanding pain management.
Other committee members voiced concern that the reformulation results in patients switching from intravenous and intranasal abuse to oral abuse. Committed abusers can still swallow multiple pills.
Some members noted that reformulated OxyContin coincided with increased transition to heroin, which is relatively cheap and readily available. However, they recognized that proving causality is difficult.
The committee was reminded that the reformulated drug provides a significant barrier against, but doesn’t altogether eliminate, opioid abuse. With hot water and the right tools, the tablets can still be manipulated.
In addition, the reformulated drug will not solve the U.S. opioid epidemic, which requires a multifaceted approach. The opioid crisis, said Wilson Compton, MD, deputy director at the National Institute on Drug Abuse, has resulted in a “skyrocketing” of deaths linked to “tremendously potent” forms of fentanyl, emerging stimulant use issues, and the possible increase in drug overdoses linked to COVID-19.
A version of this article originally appeared on Medscape.com.