AbbVie to Seek FDA Nod for Vraylar as Adjunct Treatment for Major Depressive Disorder

 AbbVie Inc. on Friday said a Phase 3 study of its antipsychotic drug Vraylar as an adjunctive treatment for major depressive disorder met its primary endpoint, and that it plans to seek expanded approval in the indication from the U.S. Food and Drug Administration.

The North Chicago, Ill., biopharmaceutical company said Vraylar showed a statistically significant change from baseline to week six compared with placebo in patients with major depressive disorder.

AbbVie noted that Vraylar showed numerical improvement in depressive symptoms from baseline to week six in a second Phase 3 study but didn't achieve statistical significance.

However, the company said that based on the positive results of the first study and an earlier Phase 2/3 registration-enabling trial, along with the totality of data reported, it plans to seek FDA approval for the expanded use of the drug for the adjunctive treatment of major depressive disorder.

The FDA has previously approved Vraylar to treat depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia in adults.

AbbVie, which is developing Vraylar jointly with Hungary's Gedeomn Richter PLC, is responsible for commercialization in the U.S., Canada, Japan, Taiwan and certain Latin American countries.

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