FDA Approves Vraylar (Cariprazine) for Bipolar Depression


New indication adds to the oral antipsychotic’s portfolio of conditions.

Vraylar Bottle and Pill

The FDA has approved the supplemental new drug application for Vraylar (cariprazine, Allergan) for the treatment of depressive episodes associated with bipolar I disorder in adults. 

Originally approved in 2015, Vraylar is an oral once daily atypical antipsychotic that is also indicated for treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. 

For treatment of depression in bipolar disorder, Vraylar can be taken once daily with or without food at a starting dose of 1.5 mg or at a dose between 1.5 mg and 3 mg. 

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Vraylar is contraindicated for patients who have a known hypersensitivity to cariprazine. Adverse reactions have included rash, pruritus, urticaria, and events suggestive of angioedema. 

The recent indication addition is based on results of three trials in which cariprazine demonstrated a greater improvement than the placebo for the change from baseline to week six on the Montgomery Asberg Depression Rating scale total score. Common adverse events reported in the trials included nausea, akathisia, restlessness, and extrapyramidal symptoms. 

“Treating bipolar disorder can be very difficult because people living with the illness experience a range of depressive and manic symptoms, sometimes both at the same time, and this FDA approval gives healthcare providers a new option to treat the full spectrum of bipolar I disorder symptoms, specifically manic, mixed, and depressive episodes, with just one medication,” said Dr. Stephen Stahl, MD, PhD, Professor of Psychiatry at the University of California San Diego and lead author of the post hoc analysis. “Treating depression, mania and mixed episodes with a single medication is important for people living with, and healthcare providers treating, this complex illness. This approval can streamline a treatment decision while helping to stabilize the disorder.”


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