The U.S. Food and Drug Administration (FDA) has approved Allergan’s supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine) for the maintenance treatment of adults with schizophrenia. 

The success of VRAYLAR in the maintenance treatment of schizophrenia was based on an up to 72-week, multinational, double-blind, placebo-controlled, randomized withdrawal study in the prevention of relapse in adult patients with schizophrenia. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6 or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized either to continue their VRAYLAR dose (3, 6 or 9 mg per day) or be switched to placebo for up to 72 weeks or until a relapse occurred. Without maintenance treatment, up to 70 percent of schizophrenia patients relapse within one year. 

“We are pleased that the FDA has recognized the benefits of VRAYLAR for maintenance treatment of adults with schizophrenia. This approval demonstrates our continued investment in VRAYLAR, as well as our commitment to developing treatments that address unmet needs facing people living with mental illness.” said David Nicholson, chief research & development officer at Allergan.