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COLORADO SPRINGS– Three-month injectable paliperidone palmitate significantly delayed time to relapse compared to placebo in patients with schizophrenia, according to phase III clinical study data being presented at the biennial meeting of the 15th International Congress on Schizophrenia Research.
The study also was published in JAMA Psychiatry.
If approved, patients would be dosed with only four injections of the atypical antipsychotic per year rather than once per month, which is the current dosing for the injectable formulation. Oral atypical antipsychotics are administered daily.
“It would be nice if there were more use, in general, of the long-acting injectables, and we hope these data will encourage that because it would increase [compliance],” Dr. Adam Savitz, a researcher on the study, said in an interview. “If it gets approved, it’s something clinicians should consider their patients could benefit from.”
Janssen, maker of the drug, has filed a New Drug Application with the Food and Drug Administration for the 3-month paliperidone palmitate injection to treat schizophrenia in adults. According to a statement from the company, a regulatory action is expected on May 18, 2015, after which time Janssen plans to file for markets outside the United States.
The multicenter, international trial conducted from April 26, 2012, through April 9, 2014, included 506 adults randomized to either the study drug or to placebo. Conducted in four phases, the study began with a 3-week screening phase, followed by a flexible-dose 17-week open-label transition phase in which patients received once-monthly doses of the 1-month formulation of paliperidone palmitate (50, 75, 100, or 150 mg). During the 12-week open-label maintenance phase, patients received a single dose of the 3-month formulation at 3.5 times the stabilized dose of their once-monthly formulation dose (JAMA Psychiatry 2015; March 29 [doi.10.1001/jamapsychiatry.2015.024]).
During the final, double-blind phase, 160 stabilized patients were randomized to 3-month paliperidone palmitate (175, 263, 350, or 525 mg), once every 3 months, and 145 stabilized patients similarly received placebo.
In an interim analysis, the time from randomization to relapse significantly favored paliperidone palmitate vs. placebo (hazard ratio, 3.45; 95% confidence interval, 1.73-6.88; P < .001). The median time before relapse was 274 days for placebo but, according to Dr. Savitz, was not estimable for the study arm.
“The interim analysis more was than 270 days after randomization, so if you think about it, that’s a very long time, because even those who were switched to placebo continued to have protection from relapse after having one dose. In the final analysis, it was actually a year-long protection, after people stopped getting the medication,” Dr. Savitz said in the interview.
This primary analysis of the data, also presented this week at the 23rd annual European Congress of Psychiatry in Vienna, is based on the interim results of time to first relapse, which were strong enough to have provoked an early termination for the study.
Treatment-emergent adverse events recorded during the double blind phase occurred in 62% of the 3-month paliperidone palmitate group and in 58% of the placebo group. Headache and weight gain were the most common (9% vs. 4% and 9% vs. 3%), respectively, followed by nasopharyngitis (6% vs. 1%), and akathisia (4% vs. 1%).
Dr. Savitz recommended that if the drug is approved, “It’s important to remember that the person has to be stabilized first using the 1-month dose,” and that it not be used in people who are allergic to risperidone or who have other allergies.
Dr. Savitz is the director of clinical research, neuroscience, and psychiatry at Janssen Pharmaceuticals.
On Twitter @whitneymcknight
COLORADO SPRINGS– Three-month injectable paliperidone palmitate significantly delayed time to relapse compared to placebo in patients with schizophrenia, according to phase III clinical study data being presented at the biennial meeting of the 15th International Congress on Schizophrenia Research.
The study also was published in JAMA Psychiatry.
If approved, patients would be dosed with only four injections of the atypical antipsychotic per year rather than once per month, which is the current dosing for the injectable formulation. Oral atypical antipsychotics are administered daily.
“It would be nice if there were more use, in general, of the long-acting injectables, and we hope these data will encourage that because it would increase [compliance],” Dr. Adam Savitz, a researcher on the study, said in an interview. “If it gets approved, it’s something clinicians should consider their patients could benefit from.”
Janssen, maker of the drug, has filed a New Drug Application with the Food and Drug Administration for the 3-month paliperidone palmitate injection to treat schizophrenia in adults. According to a statement from the company, a regulatory action is expected on May 18, 2015, after which time Janssen plans to file for markets outside the United States.
The multicenter, international trial conducted from April 26, 2012, through April 9, 2014, included 506 adults randomized to either the study drug or to placebo. Conducted in four phases, the study began with a 3-week screening phase, followed by a flexible-dose 17-week open-label transition phase in which patients received once-monthly doses of the 1-month formulation of paliperidone palmitate (50, 75, 100, or 150 mg). During the 12-week open-label maintenance phase, patients received a single dose of the 3-month formulation at 3.5 times the stabilized dose of their once-monthly formulation dose (JAMA Psychiatry 2015; March 29 [doi.10.1001/jamapsychiatry.2015.024]).
During the final, double-blind phase, 160 stabilized patients were randomized to 3-month paliperidone palmitate (175, 263, 350, or 525 mg), once every 3 months, and 145 stabilized patients similarly received placebo.
In an interim analysis, the time from randomization to relapse significantly favored paliperidone palmitate vs. placebo (hazard ratio, 3.45; 95% confidence interval, 1.73-6.88; P < .001). The median time before relapse was 274 days for placebo but, according to Dr. Savitz, was not estimable for the study arm.
“The interim analysis more was than 270 days after randomization, so if you think about it, that’s a very long time, because even those who were switched to placebo continued to have protection from relapse after having one dose. In the final analysis, it was actually a year-long protection, after people stopped getting the medication,” Dr. Savitz said in the interview.
This primary analysis of the data, also presented this week at the 23rd annual European Congress of Psychiatry in Vienna, is based on the interim results of time to first relapse, which were strong enough to have provoked an early termination for the study.
Treatment-emergent adverse events recorded during the double blind phase occurred in 62% of the 3-month paliperidone palmitate group and in 58% of the placebo group. Headache and weight gain were the most common (9% vs. 4% and 9% vs. 3%), respectively, followed by nasopharyngitis (6% vs. 1%), and akathisia (4% vs. 1%).
Dr. Savitz recommended that if the drug is approved, “It’s important to remember that the person has to be stabilized first using the 1-month dose,” and that it not be used in people who are allergic to risperidone or who have other allergies.
Dr. Savitz is the director of clinical research, neuroscience, and psychiatry at Janssen Pharmaceuticals.
On Twitter @whitneymcknight
COLORADO SPRINGS– Three-month injectable paliperidone palmitate significantly delayed time to relapse compared to placebo in patients with schizophrenia, according to phase III clinical study data being presented at the biennial meeting of the 15th International Congress on Schizophrenia Research.
The study also was published in JAMA Psychiatry.
If approved, patients would be dosed with only four injections of the atypical antipsychotic per year rather than once per month, which is the current dosing for the injectable formulation. Oral atypical antipsychotics are administered daily.
“It would be nice if there were more use, in general, of the long-acting injectables, and we hope these data will encourage that because it would increase [compliance],” Dr. Adam Savitz, a researcher on the study, said in an interview. “If it gets approved, it’s something clinicians should consider their patients could benefit from.”
Janssen, maker of the drug, has filed a New Drug Application with the Food and Drug Administration for the 3-month paliperidone palmitate injection to treat schizophrenia in adults. According to a statement from the company, a regulatory action is expected on May 18, 2015, after which time Janssen plans to file for markets outside the United States.
The multicenter, international trial conducted from April 26, 2012, through April 9, 2014, included 506 adults randomized to either the study drug or to placebo. Conducted in four phases, the study began with a 3-week screening phase, followed by a flexible-dose 17-week open-label transition phase in which patients received once-monthly doses of the 1-month formulation of paliperidone palmitate (50, 75, 100, or 150 mg). During the 12-week open-label maintenance phase, patients received a single dose of the 3-month formulation at 3.5 times the stabilized dose of their once-monthly formulation dose (JAMA Psychiatry 2015; March 29 [doi.10.1001/jamapsychiatry.2015.024]).
During the final, double-blind phase, 160 stabilized patients were randomized to 3-month paliperidone palmitate (175, 263, 350, or 525 mg), once every 3 months, and 145 stabilized patients similarly received placebo.
In an interim analysis, the time from randomization to relapse significantly favored paliperidone palmitate vs. placebo (hazard ratio, 3.45; 95% confidence interval, 1.73-6.88; P < .001). The median time before relapse was 274 days for placebo but, according to Dr. Savitz, was not estimable for the study arm.
“The interim analysis more was than 270 days after randomization, so if you think about it, that’s a very long time, because even those who were switched to placebo continued to have protection from relapse after having one dose. In the final analysis, it was actually a year-long protection, after people stopped getting the medication,” Dr. Savitz said in the interview.
This primary analysis of the data, also presented this week at the 23rd annual European Congress of Psychiatry in Vienna, is based on the interim results of time to first relapse, which were strong enough to have provoked an early termination for the study.
Treatment-emergent adverse events recorded during the double blind phase occurred in 62% of the 3-month paliperidone palmitate group and in 58% of the placebo group. Headache and weight gain were the most common (9% vs. 4% and 9% vs. 3%), respectively, followed by nasopharyngitis (6% vs. 1%), and akathisia (4% vs. 1%).
Dr. Savitz recommended that if the drug is approved, “It’s important to remember that the person has to be stabilized first using the 1-month dose,” and that it not be used in people who are allergic to risperidone or who have other allergies.
Dr. Savitz is the director of clinical research, neuroscience, and psychiatry at Janssen Pharmaceuticals.
On Twitter @whitneymcknight
AT THE INTERNATIONAL CONGRESS ON SCHIZOPHRENIA RESEARCH
Key clinical point: Injectable atypical antipsychotic dosed at 3 months could improve compliance.
Major finding: Compared with placebo, 3-month formulation of paliperidone palmitate administered 4 times yearly significantly delayed time to relapse in patients with schizophrenia.
Data source: Phase III, multisite, international, 2-year randomly controlled, double-blind study of 506 adult patients with schizophrenia.
Disclosures: Dr. Savitz is the director of clinical research, neuroscience, and psychiatry at Janssen Pharmaceuticals.
