FDA Approves New Maintenance Treatment for Schizophrenia

The US Food and Drug Administration (FDA) has approved Vraylar (cariprazine) for the maintenance treatment of schizophrenia in adults.

Vraylar is also approved in the United States for the acute treatment of schizophrenia and of manic or mixed episodes of bipolar I disorder in adults.
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The approval was based on an up-to-72-week, double-blind, placebo-controlled, randomized withdrawal study of relapse prevention among adults with schizophrenia.

Results of the study indicated that relapse occurred in nearly twice as many patients treated with placebo (n = 49 of 99; 49.5%), compared with those treated with Vraylar (n = 30 of 101 29.7%).

—Christina Vogt

Reference:

Allergan receives FDA approval for use of VRAYLAR™ (cariprazine) in the maintenance treatment of schizophrenia [press release]. Dublin, IE. Allergan plc. November 13, 2017. https://www.allergan.com/news/news/thomson-reuters/allergan-receives-fda-approval-for-use-of-vraylar. Accessed November 13, 2017.