FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves Vraylar as Maintenance Treatment for Schizophrenia

Nov. 16, 2017
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Allergan received FDA approval for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar was previously approved for acute treatment of schizophrenia and manic or mixed episodes of bipolar I disorder.

According to the company, 60 to 70 percent of schizophrenia patients relapse within one year without long-term maintenance treatment.

Efficacy was based on a placebo-controlled withdrawal study, including a 20-week open-label phase where patients with schizophrenia were treated with Vraylar 3, 6 or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label phase were then randomized to either continue their dose or be switched to placebo for up to 72 weeks or until a relapse occurred.

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