FDA Clears Non-Antipsychotic Help for Agitation in Alzheimer’s Dementia
The FDA expanded the use of Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation in adults with Alzheimer’s disease–related dementia, marking the first non-antipsychotic approved for this symptom. In two randomized trials, Auvelity improved agitation measures and extended time to relapse with continued treatment. Common side effects include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction, and sweating; there is a boxed warning for suicidality in adolescents/young adults and risks of seizures, high blood pressure, and mood activation. Pre-treatment assessments include blood pressure checks and bipolar-history screening. The approval was granted to Axsome Therapeutics, supported by breakthrough therapy and priority review designations.