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FDA accepts sNDA for Vraylar for schizophrenia
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Allergan recently announced the FDA accepted a supplemental New Drug Application for Vraylar as maintenance treatment for adults with schizophrenia.
“Most patients with schizophrenia are at very high risk of relapse in the absence of antipsychotic treatment,” Herbert Meltzer, MD, of Northwestern Feinberg School of Medicine, said in a press release. “Without maintenance treatment, 60% to 70% of patients relapse within 1 year, and almost 90% relapse within 2 years. These new data show that Vraylar may be a treatment option for the maintenance treatment of schizophrenia.”
The supplemental New Drug Application (sNDA) included data from a phase 3 multinational, randomized, double-blind, placebo-controlled, parallel-group study among adults with schizophrenia. The study included a 20-week open-label phase in which participants received 3, 6 or 9 mg of Vraylar (cariprazine, Allergan) per day. Participants who met stabilization criteria were then randomized to receive 3, 6 or 9 mg of cariprazine per day or placebo for up to 72 weeks of until relapse.
Participants who received cariprazine were less likely to relapse, compared with those who received placebo (24.8% vs. 47.5%).
At the end of double-blind treatment, mean symptom worsening indicated by Positive and Negative Syndrome Scale total and subscale scores, Clinical Global Impressions-Severity rating scale, the 16-item Negative Symptom Assessment and the Personal and Social Performance Scale total scores was greater among participants who received placebo, compared with those who received cariprazine.
Researchers did not find new safety concerns.
“These phase 3 data offer additional information about the long-term efficacy and safety of Vraylar for the maintenance treatment of schizophrenia,” C. David Nicholson, PhD, chief research and development officer at Allergan, said in the release. “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.”