Officials with the FDA have approved a supplemental New Drug Application for cariprazine (Vraylar, Allergan and Gedeon Richter), expanding the drug's use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

The drug also is approved to treat manic or mixed episodes associated with bipolar I disorder in adults. The new indication makes cariprazine the first and only dopamine and serotonin partial agonist to treat the full spectrum of bipolar I symptoms in manic, mixed, and depressive episodes, according to Allergan.

The new approval for expanded indication can streamline a treatment decision while helping to stabilize the disorder, according to Dr Stephen Stahl, Professor of Psychiatry at the University of California San Diego and lead author of the post hoc analysis, Cariprazine Efficacy in Patients with Bipolar Depression and Concurrent Manic 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 health care providers a new option to treat the full spectrum of bipolar I disorder symptoms, specifically manic, mixed, and depressive episodes, with just 1 medication," said Stahl, in a prepared statement. "Treating depression, mania and mixed episodes with a single medication is important for people living with, and healthcare providers treating, this complex illness."

The FDA’s new approval is based on 3 pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56, in which cariprazine demonstrated greater improvement than placebo for the change from baseline to week 6 on the Montgomery Asberg Depression Rating scale (MADRS) total score, according to Allergan. In all 3 studies, the cariprazine 1.5 mg dose demonstrated statistical significance over placebo; additionally, in RGH-MD-54, the cariprazine 3 mg dose demonstrated statistical significance over placebo.

Common adverse events reported in the pivotal trials were nausea, akathisia, restlessness, and extrapyramidal symptoms. 

"This approval represents an important milestone in our efforts to help patients and prescribing health care providers effectively manage bipolar I disorder and demonstrates our ongoing focus on mental health," said David Nicholson, Chief Research & Development Officer at Allergan.  "We are committed to developing therapies for complex mental health disorders, including Vraylar, which is currently in Phase 3 clinical trials for the treatment of major depressive disorder."


Allergan and Gedeon Richter Receive U.S. FDA Approval For Expanded Use of VRAYLAR® (cariprazine) in the Treatment of Bipolar Depression [news release]. Dublin and Budapest; May 28, 2019: Allergan. Accessed May 28, 2019.