FDA Approves First Non-Antipsychotic Drug To Treat Agitation Associated With Dementia

The U.S. Food and Drug Administration (FDA) has approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with Alzheimer's disease dementia in adults. Auvelity is the first non-antipsychotic drug approved for this indication. The FDA originally approved Auvelity in 2022 for major depressive disorder in adults.

The FDA granted Auvelity breakthrough therapy and priority review designations for this indication. Approval was granted to Axsome Therapeutics.

Agitation is a common symptom in Alzheimer's disease dementia, presenting as excessive motor activity or verbal and physical aggression, and can significantly . . .