US central nervous system specialist Axsome Therapeutics (Nasdaq: AXSM) saw its shares close up more than 40% at $59.55 on Friday, after it revealed that the US Food and Drug Administration (FDA) has approved its Auvelity (dextromethorphan HBr-bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults.
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. It is viewed as a game-changing option and Axsome said it expects to launch Auvelity in the fourth quarter.
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