Axsome Therapeutics, Inc. (NASDAQ:AXSM) today announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITYTM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults.1 AUVELITY is the first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week.1-4 The rapid antidepressant effects of AUVELITY were sustained at all subsequent timepoints.1 AUVELITY is the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for the treatment of MDD.3 Axsome anticipates AUVELITY to be commercially available in the U.S. in the fourth quarter of 2022.
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