FDA accepts Allergan filing for schizophrenia maintenance treatment drug

The U.S. Food and Drug Administration has accepted Allergan PLC's filing of a supplemental New Drug Application based on new clinical data that would allow the company to list maintenance on its product label for VRAYLAR (cariprazine), a drug used to treat adults with schizophrenia.
"These Phase 3 data offer additional information about the long-term efficacy and safety of VRAYLAR for the maintenance treatment of schizophrenia," Allergan Global R&D President and Executive Vice President David Nicholson said. "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."
The sNDA features data from a Phase 3 study of VRAYLAR as a maintenance treatment. The multinational study was randomized, double blind and placebo-controlled and featured parallel groups. The patients were given cariprazine in 3, 6 or 9 mg doses for 20 weeks before, if they responded and met the stabilization criteria, moving onto the study where they received the same dosage for 72 weeks or until they relapsed.
Relapse occurred in patients who received cariprazine 24.8 percent of the time, compared to 47.5 percent of patients who received placebos, who also showed a great mean worsening of symptoms.
"Most patients with schizophrenia are at very high risk of relapse in the absence of antipsychotic treatment," Northwestern Feinberg School of Medicine professor of psychiatry Dr. Herbert Meltzer said. "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."