FDA accepts sNDA to expand Vraylar indication for bipolar depression

Gary Sachs

The FDA has accepted Allergan’s supplemental New Drug Application for Vraylar seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder in adults, according to a press release.

The application is supported by positive data from three pivotal trials, two of which were phase 3 studies.

Overall, Vraylar (cariprazine, Allergan) was well-tolerated in the trials. All three trials showed cariprazine 1.5 mg and 3 mg demonstrated greater improvement over the course of 6 weeks compared with placebo in reducing depressive symptoms associated with bipolar I depression based on the Montgomery Asberg Depression Rating scale total score.

The most commonly reported adverse events included nausea, akathisia, restlessness and upper respiratory tract infection. Adverse events led to discontinuation in 6.7% of cariprazine-treated patients and 4.8% of placebo treated patients, according to the release.

“Despite decades of development, bipolar depression remains difficult to treat. Importantly, bipolar I patients will need treatment for the full spectrum of their disorder," Gary Sachs, MD, associate clinical professor of psychiatry at Harvard Medical School, said in the release. “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.”

Cariprazine, approved by the FDA in September 2015, is currently marketed for the treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Disclosure: Sachs reports a consulting agreement with Allergan under which his fees are donated to the Depression and Bipolar Support Alliance.