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Dextromethorphan HBr-buproprion HCl has been FDA approved in extended-release tablet form for MDD. The study supporting the approval showed improved MADRS total score at 6 weeks (15.9 points for Auvelity vs 12.1 points for placebo) and a statistically significant difference in the change from baseline in MADRS total score at weeks 1 and 2 between Auvelity (AXSOME) and placebo.
“The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile.”
Maurizio Fava, MD, Psychiatrist-In-Chief, Massachusetts General Hospital
