Axsome Therapeutics announces FDA approval of AUVELITY for Alzheimer's disease agitation

Axsome Therapeutics, Inc.

AUVELITY (dextromethorphan HBr/bupropion HCl) approved for agitation associated with dementia due to Alzheimer's disease.
First-in-class NMDA/sigma-1 receptor-targeted treatment; supported by Phase 3 ADVANCE-1 and ACCORD-2 trials.
In ADVANCE-1, AUVELITY showed statistically significant improvement vs placebo on CMAI at Week 5 (primary endpoint).
In ACCORD-2, AUVELITY significantly delayed time to relapse vs placebo (up to 6-month double-blind phase).
Safety profile: 1.3% discontinuation due to adverse events (same as placebo); common side effects: dizziness, dyspepsia.

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