Approvals

The Food and Drug Administration (FDA) on April 30 approved an expanded use for dextromethorphan hydrobromide and bupropion hydrochloride extended release, for the treatment of agitation associated with dementia due to Alzheimer's disease in adults. This is the first non-antipsychotic medication approved for this indication. Marketed as Auvelity by Axsome Therapeutics, the medication was found to be efficacious in two randomized trials: a 5-week placebo-controlled trial and a withdrawal study measuring time to relapse in patients who had responded to Auvelity. Common side effects associated with Auvelity are dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction, and uncontrolled sweating. The FDA in 2022 approved Auvelity for the treatment of major depressive disorder in adults. [https://www.fda.gov/news-events/press-announcements/fda-approves-first-non-antipsychotic-drug-treat-agitation-associated-dementia]