Axsome Therapeutics wins FDA for novel antidepressant Auvelity

The biopharma Axsome Therapeutics (Nasdaq:AXSM) has won FDA approval for Auvelity (dextromethorphan HBr-bupropion HCl) extended-release tablets for treating major depressive disorder (MDD) in adults.

Auvelity is the only rapid-acting oral medicine for MDD with labeling describing statistically significant antidepressant efficacy at one week. Clinical trial data also show that the drug maintains efficacy at week 6. 

Axsome Therapeutics concludes that the drug represents the first new mode of action for MDD in more than 60 years. 

The company also notes that the drug is the only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for MDD. 

“It is important to highlight that MDD is a serious, chronic, disabling and even life-threatening condition with very high rates of morbidity and mortality,” said NYU Langone psychiatrist Dr. Dan Iosifescu in an Axsome webinar. “The morbidity seen in patients with MDD includes profound distress, inabilit…

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