U.S. Food and Drug Administration (FDA) has accepted Allergan’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, said the company.
Furthermore, 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 company said.
“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.
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.