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APR 30 2026
APPROVED · 152 DAYS AGO

Axsome Therapeutics — Auvelity (dextromethorphan/bupropion) $AXSM

for Agitation in Alzheimer's dementia

NDA

FDA approved Auvelity (dextromethorphan/bupropion) for agitation associated with dementia due to Alzheimer's disease.

About

Alzheimer's disease is a neurodegenerative condition that causes memory loss and can lead to severe behavioral issues like agitation, mood swings, and social withdrawal. Auvelity is a combination of two drugs, dextromethorphan and bupropion, which work together to increase activity in brain pathways involved in mood and stress regulation. This may help calm the agitation that often accompanies Alzheimer's, potentially improving daily life for those affected.

Pivotal trial

ACCORD-2 Phase 3 completed NCT04947553

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Source: ClinicalTrials.gov

Also in development