FDA to Review Vraylar for Maintenance Treatment of Schizophrenia

The submission is based a trial whose primary endpoint was time to first relapse during the double-blind phase
The submission is based a trial whose primary endpoint was time to first relapse during the double-blind phase

Allergan announced that the Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the addition of new data evaluating Vraylar for the maintenance of efficacy in adults with schizophrenia.

The data comes from a Phase 3, multinational, randomized, double-blind, placebo-controlled, parallel-group study of cariprazine in adults with schizophrenia (RG-MD-06). In the study, treatment with cariprazine significantly delayed time to relapse compared to placebo (P=0.0010, 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 3mg, 6mg, or 9mg daily. Patients who were responsive and met the stabilization criteria were then randomized to continue their cariprazine dose (3mg, 6mg, or 9mg daily) 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. The study found relapse occurred in nearly twice as many placebo- vs. cariprazine-treated patients (47.5% vs. 24.8%). An analysis further showed a greater mean worsening of symptoms in placebo- vs. cariprazine-treated patients on all efficacy parameters as measured by PANSS (total and subscale), the CGI-S rating scale, the NSA-16, and the PSP total score. No new safety concerns were seen. 

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David Nicholson, President and EVP, Global R&D at Allergan, added, "These Phase 3 data offer additional information about the long-term efficacy and safety of Vraylar for the maintenance treatment of schizophrenia." 

Vraylar, an atypical antipsychotic, is indicated for the acute treatment of manic or mixed episodes of bipolar I disorder and the treatment of schizophrenia in adults. 

For more information call (800) 433-8871 or visit Vraylar.com.