WEDNESDAY, May 6, 2026 (HealthDay News) -- The U.S. Food and Drug Administration has approved the expanded use of Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat adults with agitation associated with dementia due to Alzheimer disease.
Auvelity was initially approved in 2022 to treat major depressive disorder in adults and is the first nonantipsychotic approved for agitation associated with dementia due to Alzheimer disease.
The approval was based on a five-week trial in which participants received either Auvelity or a placebo. Those randomly assigned to Auvelity showed a significantly greater change in the primary end point of total score of the Cohen-Mansfield Agitation Inventory based on caregiver reports. Among those who achieved a response, those who were randomly assigned to continue Auvelity treatment had a significantly longer time to relapse of agitation symptoms versus patients subsequently assigned to receive placebo.
"Auvelity was found to be efficacious for treating agitation in Alzheimer’s disease in two randomized trials and now represents an additional option to address one of the most difficult sequelae of the disease, especially as it progresses," Tracy Beth Hoeg, M.D., Ph.D., from the FDA Center for Drug Evaluation and Research, said in a statement. "We hope this approval will provide meaningful benefit to patients, their families, and caregivers."
Expanded approval of Auvelity was granted to Axsome Therapeutics.
