APR 30 2026
Axsome Therapeutics — Auvelity (dextromethorphan/bupropion) $AXSM
for Agitation in Alzheimer's dementia
FDA approved Auvelity (dextromethorphan/bupropion) for agitation associated with dementia due to Alzheimer's disease.
About
Alzheimer's disease is a progressive brain disorder that impairs memory and thinking, and it often leads to distressing behavioral issues like mood swings and agitation. Auvelity is a combination pill containing dextromethorphan, which calms brain signaling, and bupropion, which helps sustain those calming effects. This dual-action approach may help reduce the specific agitation that can significantly disrupt daily life for people with this condition.
Pivotal trial
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Auvelity
- Auvelity Expands Treatment Options for Agitation in Alzheimer’s - Psychiatry Online
- Auvelity’s Approval Just Rewrote the Rules for Dementia Agitation Trials - The Clinical Trial Vanguard
- TD Cowen raises Axsome Therapeutics price target on Auvelity growth - Investing.com
- Axsome Therapeutics Readies Auvelity Alzheimer’s Agitation Launch, Expands CNS Pipeline - Yahoo Finance
- Axsome Therapeutics Readies Auvelity Alzheimer’s Agitation Launch, Expands CNS Pipeline - The Globe and Mail
Sponsor Watch — recent news on Axsome Therapeutics
- Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy
- Axsome Therapeutics Initiates FOCUS-2 Phase 3 Trial of Solriamfetol in Children with Attention Deficit Hyperactivity Disorder (ADHD)
- Axsome Therapeutics Initiates FOCUS-3 Phase 3 Trial of Solriamfetol in Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)