FDA Accepts Supplemental New Drug Application for Allergan’s VRAYLAR

Allergan has announced that the U.S. Food and Drug Administration (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.

"Most patients with schizophrenia are at very high risk of relapse in the absence of antipsychotic treatment," said Dr. Herbert Meltzer, Professor of Psychiatry at Northwestern Feinberg School of Medicine. "Without maintenance treatment, 60–70 percent of patients relapse within one year, and almost 90 percent relapse within two years. These new data show that VRAYLAR may be a treatment option for the maintenance treatment of schizophrenia."

The data included in the sNDA are from a Phase 3 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.

"These Phase 3 data offer additional information about the long-term efficacy and safety of VRAYLAR for the maintenance treatment of schizophrenia," said David Nicholson, President and EVP, Global R&D at Allergan. "This sNDA filing is part of our commitment to mental health, and we continue to pursue research that will provide physicians and patients with comprehensive information needed to make educated choices regarding treatment options."

Cariprazine was approved by the FDA in September 2015 and is marketed as VRAYLAR™ in the US for the acute treatment of manic or mixed episodes of Bipolar I Disorder and the treatment of Schizophrenia in adults.