Axsome Announces FDA Approval Of Auvelity For Treatment Of Major Depressive Disorder

Axsome Therapeutics, Inc. (AXSM) announced the FDA has approved AUVELITY extended-release tablets for the treatment of major depressive disorder in adults. The company noted that AUVELITY is the first and only rapid-acting oral medicine approved for the treatment of major depressive disorder with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week. Axsome expects AUVELITY to be commercially available in the U.S. in the fourth quarter of 2022.

The FDA granted Breakthrough Therapy designation for AUVELITY in March 2019. The AUVELITY New Drug Application was evaluated by the FDA under Priority Review.

Shares of Axsome Therapeutics are up 20% in pre-market trade on Friday.

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