Phase 3 Trial of Cariprazine for Bipolar Depression Yields Positive Results

Allergan and Gedeon Richter reported positive topline results for their phase 3 study of Vraylar (cariprazine) for the treatment of bipolar I depression. Participants in both the 1.5 mg and 3 mg cariprazine dose groups showed a significantly greater improvement than the placebo group in change from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

The medication was generally well tolerated in this study; sedation, somnolence, dizziness, akathisia, and nausea were the most commonly reported adverse events related to treatment.

Vraylar is approved for the treatment of schizophrenia as well as for acute manic or mixed episodes associated with bipolar I disorder. According to Allergan, the company plans to submit a supplemental New Drug Application to the Food and Drug Administration for the added indication of bipolar depression later this year.