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APR 30 2026
APPROVED · 34 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 progressively damages memory and cognitive function, often leading to mood swings, social withdrawal, and behavioral challenges like agitation. Auvelity combines dextromethorphan, which affects brain signaling, with bupropion, a drug that helps sustain dextromethorphan's activity in the body. This dual-action approach may help regulate the overactive brain signals linked to agitation, potentially improving daily life for those with Alzheimer's-related distress.

Pivotal trial

ADVANCE-2 Phase 3 completed NCT05557409

This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.

Source: ClinicalTrials.gov

Also in development