Axsome Therapeutics announced FDA approval of AUVELITY (dextromethorphan HBr and bupropion HCl) for treating agitation associated with dementia due to Alzheimer’s disease on April 30, 2026. AUVELITY is a first-in-class treatment targeting NMDA and sigma-1 receptors and was developed with FDA Breakthrough Therapy designation and Priority Review evaluation. The approval marks the second neuropsychiatric indication for AUVELITY, which was previously approved for major depressive disorder in adults.
Alzheimer’s disease affects more than 7 million Americans and is the most common form of dementia. Agitation is reported in up to 76% of patients with Alzheimer’s disease and is characterized by emotional distress, verbal and physical aggressiveness, disruptive irritability, and disinhibition. Agitation has been associated with accelerated cognitive decline, increased caregiver burden, and increased mortality risk, making it a leading cause of assisted living or nursing home placement.
The FDA approval is supported by Phase 3 clinical trials ADVANCE-1 and ACCORD-2. In the 5-week ADVANCE-1 study, AUVELITY was statistically significantly superior to placebo on the Cohen-Mansfield Agitation Inventory (CMAI) total score at Week 5, the primary endpoint. On the secondary endpoint of response on the modified Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC), a statistically significantly greater proportion of patients treated with AUVELITY were rated as at least minimally improved compared to placebo. In the long-term ACCORD-2 randomized withdrawal trial, patients who continued AUVELITY treatment experienced a statistically significantly longer time to relapse of agitation symptoms compared to those switched to placebo.
Safety and tolerability were established across short-term and long-term trials. In ADVANCE-1, the most common adverse reactions occurring at 5% incidence or greater for AUVELITY and more than twice as frequently as placebo were dizziness and dyspepsia. Only 1.3% of patients discontinued AUVELITY due to an adverse event, matching the placebo discontinuation rate. To date, AUVELITY has been administered to more than 300,000 patients in clinical and real-world settings. The Auvelity OnMySide patient support program provides comprehensive support services including a savings card, samples program, and prior authorization support.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.financialcontent.com/article/gnwcq-2026-4-30-axsome-therapeutics-announces-fda-approval-of-auvelity-dextromethorphan-hbr-and-bupropion-hcl-for-the-treatment-of-agitation-associated-with-dementia-due-to-alzheimers-disease