FDA approves Auvelity for agitation associated with dementia due to Alzheimer’s disease

The U.S. Food and Drug Administration has approved Auvelity (dextromethorphan HBr and bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease, Axsome Therapeutics said on April 30, 2026. The oral therapy is described as a first-in-class treatment for Alzheimer’s disease agitation that targets the N-methyl D-aspartate (NMDA) and sigma-1 receptors.

According to the company, Auvelity was granted FDA Breakthrough Therapy designation and evaluated under Priority Review. Axsome said the safety and tolerability profile of Auvelity in this indication has been established across short-term and long-term trials.

“This approval marks an important milestone for patients living with Alzheimer’s disease, their families, and their caregivers,” said Herriot Tabuteau, MD, chief executive of Axsome. He said the decision provides clinicians and patients with a new FDA-approved option with a distinct mechanism of action for a condition the company characterized as critically underserved.

Alzheimer’s disease is the most common form of dementia and affects more than 7 million Americans. Beyond cognitive decline, agitation is reported in up to 76% of patients with Alzheimer’s disease and can manifest as pacing or restlessness as well as verbal and physical aggression.

The condition is described as one of the most persistent, complex, stressful and costly aspects of care among patients with behavioral and psychological symptoms of Alzheimer’s disease.

“Agitation is highly prevalent in patients with Alzheimer’s disease and among the most burdensome aspects of the disease for patients and families,” said Jeffrey Cummings, MD, ScD, Chambers-Grundy Professor of Brain Sciences at the UNLV Kirk Kerkorian School of Medicine.

He noted that Alzheimer’s disease agitation is associated with accelerated cognitive decline, placement in assisted living and long-term care facilities, and increased mortality risk, and called treatment for this symptom a critical unmet medical need. “The approval of Auvelity for this condition has the potential to play an important role in patient care,” he said.

George Grossberg, MD, professor and director of the Division of Geriatric Psychiatry at the Saint Louis University School of Medicine, said agitation in patients with dementia due to Alzheimer’s disease is distressing and challenging for patients, caregivers, and clinicians.

He said Auvelity is the only FDA-approved product to result in a statistically significantly longer time to relapse of agitation symptoms, compared with placebo, in a long-term study, and he described its safety and tolerability profile as compelling, with discontinuation rates due to adverse events that were low and matched those of placebo.

Axsome said Alzheimer’s disease agitation is the second neuropsychiatric indication for which Auvelity has received FDA Breakthrough Therapy designation and been granted Priority Review and approval.