Allergan files supplemental sNDA at FDA for maintenance of efficacy in adults with schizophrenia with Vraylar (cariprazine).
Allergan plc announced that the FDA has accepted for filing the company's supplemental New Drug Application (sNDA) for Vraylar (cariprazine), seeking the addition of new clinical data evaluating Vraylar for the maintenance of efficacy in adults with schizophrenia to the current product label.
The data included in the sNDA are from a Phase III multinational, randomized, double-blind, placebo-controlled, parallel-group study of cariprazine in adults with schizophrenia (RG-MD-06), which found cariprazine compared to placebo significantly delayed the time to relapse (p=.0010, hazard ratio [HR]: 0.45 [95% CI: 0.28, 0.73]). The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6 or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized to continue their cariprazine dose (3, 6 or 9 mg per day) or switched to placebo for up to 72 weeks or until a relapse occurred. The primary endpoint was time to first symptom relapse during the double blind phase.
Relapse occurred in nearly twice as many placebo- (47.5%) as cariprazine-treated (24.8%) patients. At the end of the double-blind treatment period, analysis of exploratory endpoints also showed a greater mean worsening of symptoms in placebo- vs cariprazine-treated patients on all efficacy parameters as measured by Positive and Negative Syndrome Scale (PANSS) total and subscale scores, the Clinical Global Impressions-Severity (CGI-S) rating scale, the 16-Item Negative Symptom Assessment (NSA-16) and the Personal and Social Performance Scale (PSP) total score. The safety results were consistent with the profile observed to date for cariprazine ; no new safety concerns were observed.
Comment: The FDA approved Vraylar in 2015 to treat schizophrenia and bipolar disorder and in April 2016 Gedeon Richter, the originator of the drug filed the drug with EMA . Recordati have licensed rights to Western Europe, Algeria,Tunisia and Turkey.
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