Mary Jo Dales

A low-dose sublingual formulation of zolpidem tartrate is the first agent to be approved to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep, the Food and Drug Administration announced Nov. 23.

Zolpidem tartrate was first approved in the United States in 1992 as the higher-dose formulation known as Ambien.

"For people whose insomnia causes them to wake in the middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," said Dr. Robert Temple, deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research, in a statement. "With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving."

Intermezzo (Transcept Pharmaceuticals Inc.) should only be used when a person has at least 4 hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.

The recommended and maximum dose of Intermezzo is 1.75 mg for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.

Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, patients taking the drug fell back to sleep faster after awakening as compared to people taking a placebo. The most commonly reported adverse reactions in the clinical trials were headache, nausea, and fatigue.

Potential side effects include getting out of bed while not fully awake and undertaking activities that are not remembered. Reported and not remembered activities have included driving a car, making and eating food, having sex, talking on the phone, and sleepwalking. Risks of such activities increase with use of alcohol or sedating drugs.

Intermezzo is a federally controlled substance.

A low-dose sublingual formulation of zolpidem tartrate is the first agent to be approved to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep, the Food and Drug Administration announced Nov. 23.

Zolpidem tartrate was first approved in the United States in 1992 as the higher-dose formulation known as Ambien.

"For people whose insomnia causes them to wake in the middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," said Dr. Robert Temple, deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research, in a statement. "With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving."

Intermezzo (Transcept Pharmaceuticals Inc.) should only be used when a person has at least 4 hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.

The recommended and maximum dose of Intermezzo is 1.75 mg for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.

Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, patients taking the drug fell back to sleep faster after awakening as compared to people taking a placebo. The most commonly reported adverse reactions in the clinical trials were headache, nausea, and fatigue.

Potential side effects include getting out of bed while not fully awake and undertaking activities that are not remembered. Reported and not remembered activities have included driving a car, making and eating food, having sex, talking on the phone, and sleepwalking. Risks of such activities increase with use of alcohol or sedating drugs.

Intermezzo is a federally controlled substance.

A low-dose sublingual formulation of zolpidem tartrate is the first agent to be approved to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep, the Food and Drug Administration announced Nov. 23.

Zolpidem tartrate was first approved in the United States in 1992 as the higher-dose formulation known as Ambien.

"For people whose insomnia causes them to wake in the middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," said Dr. Robert Temple, deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research, in a statement. "With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving."

Intermezzo (Transcept Pharmaceuticals Inc.) should only be used when a person has at least 4 hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.

The recommended and maximum dose of Intermezzo is 1.75 mg for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.

Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, patients taking the drug fell back to sleep faster after awakening as compared to people taking a placebo. The most commonly reported adverse reactions in the clinical trials were headache, nausea, and fatigue.

Potential side effects include getting out of bed while not fully awake and undertaking activities that are not remembered. Reported and not remembered activities have included driving a car, making and eating food, having sex, talking on the phone, and sleepwalking. Risks of such activities increase with use of alcohol or sedating drugs.

Intermezzo is a federally controlled substance.

Infliximab is approved for use in children over age 6 years who have moderately to severely active ulcerative colitis and an inadequate response to conventional therapy, the Food and Drug Administration announced on Sept. 23.

While the tumor necrosis factor (TNF) blocker offers another therapeutic option for these children, "there are serious risks associated with its use," said Dr. Donna Griebel, director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research.

The FDA’s Gastrointestinal Drugs Advisory Committee unanimously voted on July 21 that the risk-benefit profile of infliximab (Remicade, Janssen Biotech Inc.) supported this indication. All but one panelist voted that safety concerns remained that still had not been adequately addressed, particularly with long-term treatment. The recommendation was based on the results of a multicenter, randomized, open-label study in 60 children aged 6-17 years with moderately to severely active ulcerative colitis that had failed to respond to or to tolerate conventional treatment.

Infliximab carries a boxed warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and infections caused by viruses, fungi, or bacteria. Cases of unusual cancers have been reported in adolescent and young adult patients using TNF-blocking agents, including cases of hepatosplenic T-cell lymphoma.

In its announcement of the approval, the FDA stated that children should have all of their vaccines brought up to date before starting treatment with infliximab and should not receive live vaccines while taking the drug. According to the FDA, the most common side effects of infliximab are worsening of ulcerative colitis, upper respiratory infections, infusion-related reactions, and headache.

Infliximab also is approved for the treatment of Crohn’s disease in adults and children older than 6 years, as well as for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis in adults.

According to the FDA, 50,000-100,000 children in the United States have inflammatory bowel disease and, of those, 40% have ulcerative colitis.

Infliximab is approved for use in children over age 6 years who have moderately to severely active ulcerative colitis and an inadequate response to conventional therapy, the Food and Drug Administration announced on Sept. 23.

While the tumor necrosis factor (TNF) blocker offers another therapeutic option for these children, "there are serious risks associated with its use," said Dr. Donna Griebel, director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research.

The FDA’s Gastrointestinal Drugs Advisory Committee unanimously voted on July 21 that the risk-benefit profile of infliximab (Remicade, Janssen Biotech Inc.) supported this indication. All but one panelist voted that safety concerns remained that still had not been adequately addressed, particularly with long-term treatment. The recommendation was based on the results of a multicenter, randomized, open-label study in 60 children aged 6-17 years with moderately to severely active ulcerative colitis that had failed to respond to or to tolerate conventional treatment.

Infliximab carries a boxed warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and infections caused by viruses, fungi, or bacteria. Cases of unusual cancers have been reported in adolescent and young adult patients using TNF-blocking agents, including cases of hepatosplenic T-cell lymphoma.

In its announcement of the approval, the FDA stated that children should have all of their vaccines brought up to date before starting treatment with infliximab and should not receive live vaccines while taking the drug. According to the FDA, the most common side effects of infliximab are worsening of ulcerative colitis, upper respiratory infections, infusion-related reactions, and headache.

Infliximab also is approved for the treatment of Crohn’s disease in adults and children older than 6 years, as well as for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis in adults.

According to the FDA, 50,000-100,000 children in the United States have inflammatory bowel disease and, of those, 40% have ulcerative colitis.

Infliximab is approved for use in children over age 6 years who have moderately to severely active ulcerative colitis and an inadequate response to conventional therapy, the Food and Drug Administration announced on Sept. 23.

While the tumor necrosis factor (TNF) blocker offers another therapeutic option for these children, "there are serious risks associated with its use," said Dr. Donna Griebel, director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research.

The FDA’s Gastrointestinal Drugs Advisory Committee unanimously voted on July 21 that the risk-benefit profile of infliximab (Remicade, Janssen Biotech Inc.) supported this indication. All but one panelist voted that safety concerns remained that still had not been adequately addressed, particularly with long-term treatment. The recommendation was based on the results of a multicenter, randomized, open-label study in 60 children aged 6-17 years with moderately to severely active ulcerative colitis that had failed to respond to or to tolerate conventional treatment.

Infliximab carries a boxed warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and infections caused by viruses, fungi, or bacteria. Cases of unusual cancers have been reported in adolescent and young adult patients using TNF-blocking agents, including cases of hepatosplenic T-cell lymphoma.

In its announcement of the approval, the FDA stated that children should have all of their vaccines brought up to date before starting treatment with infliximab and should not receive live vaccines while taking the drug. According to the FDA, the most common side effects of infliximab are worsening of ulcerative colitis, upper respiratory infections, infusion-related reactions, and headache.

Infliximab also is approved for the treatment of Crohn’s disease in adults and children older than 6 years, as well as for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis in adults.

According to the FDA, 50,000-100,000 children in the United States have inflammatory bowel disease and, of those, 40% have ulcerative colitis.

CHICAGO - Screening for ovarian cancer did not reduce the risk of dying from the disease for women with average risk, according to results of a multicenter screening study of nearly 80,000 women.

Screening nearly 40,000 post-menopausal women with transvaginal ultrasound for 4 years and CA-124 for 6 years did not decrease ovarian cancer mortality compared to nearly 40,000 control women. Further, there was evidence of harm in the 3,285 women with false positive results; 1080 women had surgery and 163 of them had 222 major complications, according to Dr. Saundra Buys, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, whose presentation of the data was given on June 4 at the annual meeting of the American Society of Clinical Oncology. The study appears in the June 8 issue of JAMA (2011;305:2295-303). 

Among women who underwent screening, 118 died of ovarian cancer, whereas 100 women who received usual care died as a result of the disease. The difference was not significant.

"It is possible that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening," Dr. Buys said.

More ovarian cancers were diagnosed in the screened women (212 vs. 176), although this difference was not significant. This suggests "that some of the additional cancers detected by screening were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their lifetimes," for example, with overdiagnosis, the researchers observed. Stage III and IV cancers were the most common in each group (77% of the screening group and 78% of the usual care group).

The women in this study were part of the PLCO (Prostate, Lung, Colorectal and Ovarian) cancer screening trial. In all, 68,557 women aged 55-74 years were assigned to either annual screening (34,253 women) or usual care (34,304 women) in 1993-2001 and remained in the analysis. Women in the screening arm were offered annual CA 125 testing for 6 years and transvaginal ultrasound for 4 years. Those in the usual care arm were not offered the screening tests. The median follow-up was 12.4 years.

Women with a CA 125 level of 35 U/mL or greater were classified as abnormal. Transvaginal ultrasound was conducted using a 5-7.5 MHz transvaginal probe. Results were considered abnormal if the ovarian volume was greater than 10 cm³, if the cyst volume was greater than 10 cm³, if any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size was present, or if any mixed (solid and cystic) component within a cystic ovarian tumor was present.

Both the women and their physicians were notified in writing about suspicious abnormalities found through screening. The women’s primary care physicians were responsible for managing the diagnostic process to assess abnormalities.

Among women in the screening arm, there were a greater number of false positives (3,285 false positives vs. 212 true positives). Of women who had a false positive test, one-third (1,080 women) underwent surgery for biopsy to evaluate positive test results. Of these, 163 (15%) women had 222 distinct major complications.

One of the authors, Jonathan D. Clapp, reported having a financial interest in Human Genome Sciences Inc. The other authors reported that they had no relevant financial relationships. The National Cancer Institute funded the PLCO cancer screening trial.

Kerri Wachter contributed to this article.

CHICAGO - Screening for ovarian cancer did not reduce the risk of dying from the disease for women with average risk, according to results of a multicenter screening study of nearly 80,000 women.

Screening nearly 40,000 post-menopausal women with transvaginal ultrasound for 4 years and CA-124 for 6 years did not decrease ovarian cancer mortality compared to nearly 40,000 control women. Further, there was evidence of harm in the 3,285 women with false positive results; 1080 women had surgery and 163 of them had 222 major complications, according to Dr. Saundra Buys, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, whose presentation of the data was given on June 4 at the annual meeting of the American Society of Clinical Oncology. The study appears in the June 8 issue of JAMA (2011;305:2295-303). 

Among women who underwent screening, 118 died of ovarian cancer, whereas 100 women who received usual care died as a result of the disease. The difference was not significant.

"It is possible that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening," Dr. Buys said.

More ovarian cancers were diagnosed in the screened women (212 vs. 176), although this difference was not significant. This suggests "that some of the additional cancers detected by screening were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their lifetimes," for example, with overdiagnosis, the researchers observed. Stage III and IV cancers were the most common in each group (77% of the screening group and 78% of the usual care group).

The women in this study were part of the PLCO (Prostate, Lung, Colorectal and Ovarian) cancer screening trial. In all, 68,557 women aged 55-74 years were assigned to either annual screening (34,253 women) or usual care (34,304 women) in 1993-2001 and remained in the analysis. Women in the screening arm were offered annual CA 125 testing for 6 years and transvaginal ultrasound for 4 years. Those in the usual care arm were not offered the screening tests. The median follow-up was 12.4 years.

Women with a CA 125 level of 35 U/mL or greater were classified as abnormal. Transvaginal ultrasound was conducted using a 5-7.5 MHz transvaginal probe. Results were considered abnormal if the ovarian volume was greater than 10 cm³, if the cyst volume was greater than 10 cm³, if any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size was present, or if any mixed (solid and cystic) component within a cystic ovarian tumor was present.

Both the women and their physicians were notified in writing about suspicious abnormalities found through screening. The women’s primary care physicians were responsible for managing the diagnostic process to assess abnormalities.

Among women in the screening arm, there were a greater number of false positives (3,285 false positives vs. 212 true positives). Of women who had a false positive test, one-third (1,080 women) underwent surgery for biopsy to evaluate positive test results. Of these, 163 (15%) women had 222 distinct major complications.

One of the authors, Jonathan D. Clapp, reported having a financial interest in Human Genome Sciences Inc. The other authors reported that they had no relevant financial relationships. The National Cancer Institute funded the PLCO cancer screening trial.

Kerri Wachter contributed to this article.

CHICAGO - Screening for ovarian cancer did not reduce the risk of dying from the disease for women with average risk, according to results of a multicenter screening study of nearly 80,000 women.

Screening nearly 40,000 post-menopausal women with transvaginal ultrasound for 4 years and CA-124 for 6 years did not decrease ovarian cancer mortality compared to nearly 40,000 control women. Further, there was evidence of harm in the 3,285 women with false positive results; 1080 women had surgery and 163 of them had 222 major complications, according to Dr. Saundra Buys, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, whose presentation of the data was given on June 4 at the annual meeting of the American Society of Clinical Oncology. The study appears in the June 8 issue of JAMA (2011;305:2295-303). 

Among women who underwent screening, 118 died of ovarian cancer, whereas 100 women who received usual care died as a result of the disease. The difference was not significant.

"It is possible that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening," Dr. Buys said.

More ovarian cancers were diagnosed in the screened women (212 vs. 176), although this difference was not significant. This suggests "that some of the additional cancers detected by screening were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their lifetimes," for example, with overdiagnosis, the researchers observed. Stage III and IV cancers were the most common in each group (77% of the screening group and 78% of the usual care group).

The women in this study were part of the PLCO (Prostate, Lung, Colorectal and Ovarian) cancer screening trial. In all, 68,557 women aged 55-74 years were assigned to either annual screening (34,253 women) or usual care (34,304 women) in 1993-2001 and remained in the analysis. Women in the screening arm were offered annual CA 125 testing for 6 years and transvaginal ultrasound for 4 years. Those in the usual care arm were not offered the screening tests. The median follow-up was 12.4 years.

Women with a CA 125 level of 35 U/mL or greater were classified as abnormal. Transvaginal ultrasound was conducted using a 5-7.5 MHz transvaginal probe. Results were considered abnormal if the ovarian volume was greater than 10 cm³, if the cyst volume was greater than 10 cm³, if any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size was present, or if any mixed (solid and cystic) component within a cystic ovarian tumor was present.

Both the women and their physicians were notified in writing about suspicious abnormalities found through screening. The women’s primary care physicians were responsible for managing the diagnostic process to assess abnormalities.

Among women in the screening arm, there were a greater number of false positives (3,285 false positives vs. 212 true positives). Of women who had a false positive test, one-third (1,080 women) underwent surgery for biopsy to evaluate positive test results. Of these, 163 (15%) women had 222 distinct major complications.

One of the authors, Jonathan D. Clapp, reported having a financial interest in Human Genome Sciences Inc. The other authors reported that they had no relevant financial relationships. The National Cancer Institute funded the PLCO cancer screening trial.

Kerri Wachter contributed to this article.

Manufacturers of long-acting beta-agonists will be required to conduct five randomized, double-blind, controlled clinical trials that will compare LABAs and inhaled corticosteroids to inhaled corticosteroids alone, the Food and Drug Administration announced in an April 15 press release.

The clinical trials will begin in 2011, and the FDA expects to receive results in 2017, according to the FDA statement.

Individual clinical trials will address each of the four approved LABAs in patients 12 years of age and older. One trial will evaluate Symbicort (budesonide and formoterol), a second trial will address Advair Diskus (fluticasone and salmeterol), and a third will evaluate Dulera (mometasone and formoterol). The fourth trial will involve Foradil (formoterol) and will also include treatment with fluticasone, which will be provided in a separate inhaler. The adult and adolescent trials will include 11,700 patients in each trial for a total of 46,800 patients.

The fifth clinical trial will involve Advair Diskus and will be conducted in pediatric patients aged 4-11 years. The pediatric trial will include 6,200 patients. Patients in all trials will be treated for 6 months, and the primary end point will be a composite of serious asthma outcomes, including asthma-related death, intubation, or hospitalization. The pediatric trial will also assess other relevant quality of life end points such as days of school missed and emergency department visits because of asthma-related illness.

Last year, the FDA announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

LABAs should not be started in patients with acutely deteriorating asthma, the FDA advised. Patients and their families should be told that LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms, and patients should be told to seek immediate medical attention for deteriorating asthma.

For pediatric and adolescent patients who need the addition of a LABA to an inhaled corticosteroid, the FDA recommended prescribing a combination inhaled corticosteroid–LABA product to assure adherence to both medications.

Manufacturers of long-acting beta-agonists will be required to conduct five randomized, double-blind, controlled clinical trials that will compare LABAs and inhaled corticosteroids to inhaled corticosteroids alone, the Food and Drug Administration announced in an April 15 press release.

The clinical trials will begin in 2011, and the FDA expects to receive results in 2017, according to the FDA statement.

Individual clinical trials will address each of the four approved LABAs in patients 12 years of age and older. One trial will evaluate Symbicort (budesonide and formoterol), a second trial will address Advair Diskus (fluticasone and salmeterol), and a third will evaluate Dulera (mometasone and formoterol). The fourth trial will involve Foradil (formoterol) and will also include treatment with fluticasone, which will be provided in a separate inhaler. The adult and adolescent trials will include 11,700 patients in each trial for a total of 46,800 patients.

The fifth clinical trial will involve Advair Diskus and will be conducted in pediatric patients aged 4-11 years. The pediatric trial will include 6,200 patients. Patients in all trials will be treated for 6 months, and the primary end point will be a composite of serious asthma outcomes, including asthma-related death, intubation, or hospitalization. The pediatric trial will also assess other relevant quality of life end points such as days of school missed and emergency department visits because of asthma-related illness.

Last year, the FDA announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

LABAs should not be started in patients with acutely deteriorating asthma, the FDA advised. Patients and their families should be told that LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms, and patients should be told to seek immediate medical attention for deteriorating asthma.

For pediatric and adolescent patients who need the addition of a LABA to an inhaled corticosteroid, the FDA recommended prescribing a combination inhaled corticosteroid–LABA product to assure adherence to both medications.

Manufacturers of long-acting beta-agonists will be required to conduct five randomized, double-blind, controlled clinical trials that will compare LABAs and inhaled corticosteroids to inhaled corticosteroids alone, the Food and Drug Administration announced in an April 15 press release.

The clinical trials will begin in 2011, and the FDA expects to receive results in 2017, according to the FDA statement.

Individual clinical trials will address each of the four approved LABAs in patients 12 years of age and older. One trial will evaluate Symbicort (budesonide and formoterol), a second trial will address Advair Diskus (fluticasone and salmeterol), and a third will evaluate Dulera (mometasone and formoterol). The fourth trial will involve Foradil (formoterol) and will also include treatment with fluticasone, which will be provided in a separate inhaler. The adult and adolescent trials will include 11,700 patients in each trial for a total of 46,800 patients.

The fifth clinical trial will involve Advair Diskus and will be conducted in pediatric patients aged 4-11 years. The pediatric trial will include 6,200 patients. Patients in all trials will be treated for 6 months, and the primary end point will be a composite of serious asthma outcomes, including asthma-related death, intubation, or hospitalization. The pediatric trial will also assess other relevant quality of life end points such as days of school missed and emergency department visits because of asthma-related illness.

Last year, the FDA announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

LABAs should not be started in patients with acutely deteriorating asthma, the FDA advised. Patients and their families should be told that LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms, and patients should be told to seek immediate medical attention for deteriorating asthma.

For pediatric and adolescent patients who need the addition of a LABA to an inhaled corticosteroid, the FDA recommended prescribing a combination inhaled corticosteroid–LABA product to assure adherence to both medications.

Manufacturers of long-acting beta-agonists will be required to conduct five randomized, double-blind, controlled clinical trials that will compare LABAs and inhaled corticosteroids to inhaled corticosteroids alone, the Food and Drug Administration announced in an April 15 press release.

The clinical trials will begin in 2011, and the FDA expects to receive results in 2017, according to the FDA statement.

Individual clinical trials will address each of the four approved LABAs in patients 12 years of age and older. One trial will evaluate Symbicort (budesonide and formoterol), a second trial will address Advair Diskus (fluticasone and salmeterol), and a third will evaluate Dulera (mometasone and formoterol). The fourth trial will involve Foradil (formoterol) and will also include treatment with fluticasone, which will be provided in a separate inhaler. The adult and adolescent trials will include 11,700 patients in each trial for a total of 46,800 patients.

The fifth clinical trial will involve Advair Diskus and will be conducted in pediatric patients aged 4-11 years. The pediatric trial will include 6,200 patients. Patients in all trials will be treated for 6 months, and the primary end point will be a composite of serious asthma outcomes, including asthma-related death, intubation, or hospitalization. The pediatric trial will also assess other relevant quality of life end points such as days of school missed and emergency department visits because of asthma-related illness.

Last year, the FDA announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

LABAs should not be started in patients with acutely deteriorating asthma, the FDA advised. Patients and their families should be told that LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms, and patients should be told to seek immediate medical attention for deteriorating asthma.

For pediatric and adolescent patients who need the addition of a LABA to an inhaled corticosteroid, the FDA recommended prescribing a combination inhaled corticosteroid–LABA product to assure adherence to both medications.

Manufacturers of long-acting beta-agonists will be required to conduct five randomized, double-blind, controlled clinical trials that will compare LABAs and inhaled corticosteroids to inhaled corticosteroids alone, the Food and Drug Administration announced in an April 15 press release.

The clinical trials will begin in 2011, and the FDA expects to receive results in 2017, according to the FDA statement.

Individual clinical trials will address each of the four approved LABAs in patients 12 years of age and older. One trial will evaluate Symbicort (budesonide and formoterol), a second trial will address Advair Diskus (fluticasone and salmeterol), and a third will evaluate Dulera (mometasone and formoterol). The fourth trial will involve Foradil (formoterol) and will also include treatment with fluticasone, which will be provided in a separate inhaler. The adult and adolescent trials will include 11,700 patients in each trial for a total of 46,800 patients.

The fifth clinical trial will involve Advair Diskus and will be conducted in pediatric patients aged 4-11 years. The pediatric trial will include 6,200 patients. Patients in all trials will be treated for 6 months, and the primary end point will be a composite of serious asthma outcomes, including asthma-related death, intubation, or hospitalization. The pediatric trial will also assess other relevant quality of life end points such as days of school missed and emergency department visits because of asthma-related illness.

Last year, the FDA announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

LABAs should not be started in patients with acutely deteriorating asthma, the FDA advised. Patients and their families should be told that LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms, and patients should be told to seek immediate medical attention for deteriorating asthma.

For pediatric and adolescent patients who need the addition of a LABA to an inhaled corticosteroid, the FDA recommended prescribing a combination inhaled corticosteroid–LABA product to assure adherence to both medications.

Manufacturers of long-acting beta-agonists will be required to conduct five randomized, double-blind, controlled clinical trials that will compare LABAs and inhaled corticosteroids to inhaled corticosteroids alone, the Food and Drug Administration announced in an April 15 press release.

The clinical trials will begin in 2011, and the FDA expects to receive results in 2017, according to the FDA statement.

Individual clinical trials will address each of the four approved LABAs in patients 12 years of age and older. One trial will evaluate Symbicort (budesonide and formoterol), a second trial will address Advair Diskus (fluticasone and salmeterol), and a third will evaluate Dulera (mometasone and formoterol). The fourth trial will involve Foradil (formoterol) and will also include treatment with fluticasone, which will be provided in a separate inhaler. The adult and adolescent trials will include 11,700 patients in each trial for a total of 46,800 patients.

The fifth clinical trial will involve Advair Diskus and will be conducted in pediatric patients aged 4-11 years. The pediatric trial will include 6,200 patients. Patients in all trials will be treated for 6 months, and the primary end point will be a composite of serious asthma outcomes, including asthma-related death, intubation, or hospitalization. The pediatric trial will also assess other relevant quality of life end points such as days of school missed and emergency department visits because of asthma-related illness.

Last year, the FDA announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

LABAs should not be started in patients with acutely deteriorating asthma, the FDA advised. Patients and their families should be told that LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms, and patients should be told to seek immediate medical attention for deteriorating asthma.

For pediatric and adolescent patients who need the addition of a LABA to an inhaled corticosteroid, the FDA recommended prescribing a combination inhaled corticosteroid–LABA product to assure adherence to both medications.