Allergan announced that the Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) as a treatment for depressive episodes associated with bipolar I disorder in adults. 

The sNDA included findings from the RGH-MD-53, RGH-MD-54, and RGH-MD-56  trials in which cariprazine was associated with greater improvement in change from baseline to week 6 on the Montgomery Asberg Depression Rating scale (MADRS) total score vs placebo in bipolar I patients. Both the 1.5mg and 3mg doses showed superiority vs placebo in reducing depressive symptoms associated with bipolar I depression. Nausea, akathisia, restlessness and upper respiratory tract infection were the most commonly reported adverse events associated with cariprazine. 

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“If approved for bipolar depression, cariprazine would be the first and only partial agonist with proven efficacy for both the manic and depressive symptoms of bipolar I disorder. That is very encouraging news for patients, their families, and the psychiatry community,” stated Gary Sachs MD, Associate Clinical Professor of Psychiatry at Harvard Medical School.

Vraylar, an atypical antipsychotic, is currently indicated for the treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

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