WEDNESDAY, May 6, 2026 (NewsDay News) — The US Food and Drug Administration has approved the expanded use of Auvelity tablets (dextromethorphan hydrobromide and bupropion hydrochloride) to treat adults with dementia-related agitation from Alzheimer’s disease.
Auvelity was originally approved in 2022 for the treatment of major depressive disorder in adults and is the first non-psychotic drug approved for agitation associated with dementia from Alzheimer’s disease.
The approval is based on a five-week trial in which participants received Auvelity or a placebo. Those randomly assigned to Auvelity showed a significant change in the overall endpoint of the Cohen-Mansfield Inventory score based on caregiver reports. Among those who achieved a response, those randomly assigned to continue treatment with Auvelity had a significantly longer time to recurrence of anxiety symptoms than patients who were then assigned to receive placebo.
“In two randomized trials, Auvelity has been effective in treating agitation in Alzheimer’s disease and is now an additional option for addressing one of the most difficult consequences of this disease, especially as it progresses,” Tracy Beth Hogue, MD, Ph.D., of the FDA’s Center for Drug Evaluation and Research, said in a statement. “We hope this approval will bring significant benefits to patients, their families and caregivers.”
Auvelity’s extended approval has been granted to Axsome Therapeutics.
