FDA News

FDA approves expanded use of Vraylar for bipolar depression

Stephen Stahl

The FDA has approved a supplemental New Drug Application, or sNDA, for Vraylar for the expanded use to treat depressive episodes associated with bipolar I disorder in adults, according to a press release.

Vraylar (cariprazine, Allergan) is already approved by the FDA to treat manic or mixed episodes relating to bipolar I disorder in adults. The FDA approval for its expanded indication was based on data from three pivotal trials (RGH-MD-53, RGH-MD-54 and RGH-MD-56), according to the press release.

In the trials, cariprazine showed greater improvement on the Montgomery Asberg Depression Rating scale (MADRS) total score from baseline to week 6 compared with placebo. The 1.5-mg dose demonstrated statistical significance over placebo in all trials and the 3-mg dose demonstrated statistical significance over placebo in one of the trials (RGH-MD-54). Common adverse events included nausea, akathisia, restlessness and extrapyramidal symptoms.

"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 one medication," Stephen M. Stahl, MD, PhD, professor of psychiatry at University of California, San Diego, said in the release. "Treating depression, mania and mixed episodes with a single medication is important for people living with, and health care providers treating, this complex illness. This approval can streamline a treatment decision while helping to stabilize the disorder."

Disclosure: Stahl reports consulting for Allergan.

Stephen Stahl

The FDA has approved a supplemental New Drug Application, or sNDA, for Vraylar for the expanded use to treat depressive episodes associated with bipolar I disorder in adults, according to a press release.

Vraylar (cariprazine, Allergan) is already approved by the FDA to treat manic or mixed episodes relating to bipolar I disorder in adults. The FDA approval for its expanded indication was based on data from three pivotal trials (RGH-MD-53, RGH-MD-54 and RGH-MD-56), according to the press release.

In the trials, cariprazine showed greater improvement on the Montgomery Asberg Depression Rating scale (MADRS) total score from baseline to week 6 compared with placebo. The 1.5-mg dose demonstrated statistical significance over placebo in all trials and the 3-mg dose demonstrated statistical significance over placebo in one of the trials (RGH-MD-54). Common adverse events included nausea, akathisia, restlessness and extrapyramidal symptoms.

"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 one medication," Stephen M. Stahl, MD, PhD, professor of psychiatry at University of California, San Diego, said in the release. "Treating depression, mania and mixed episodes with a single medication is important for people living with, and health care providers treating, this complex illness. This approval can streamline a treatment decision while helping to stabilize the disorder."

Disclosure: Stahl reports consulting for Allergan.