13 November 2017 - Label expansion includes new data showing long-term Vraylar therapy delayed time to relapse compared to placebo over the course of up to 72 weeks.

Allergan today announced that the U.S. FDA has approved the supplemental new drug application for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.

The efficacy 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 stabilisation criteria during the open-label period were then randomised either to continue their Vraylar dose (3 mg, 6 mg or 9 mg per day) or be switched to placebo for up to 72 weeks or until a relapse occurred. The primary endpoint was time to relapse during the randomised, double blind phase.

Read Allergan press release