Axsome Therapeutics’ Auvelity (dextromethorphan/bupropion) won FDA approval to treat agitation in Alzheimer’s disease, giving the company access to a large, previously underserved indication. The expansion follows Auvelity’s 2022 approval for major depressive disorder and arrives on the back of FDA review using data tied to agitation efficacy. Analysts and clinicians are focused on how Auvelity’s safety profile differentiates it in a label set that includes competitive therapies and their warnings. Axsome also flagged that up to three-quarters of Alzheimer’s patients may experience agitation symptoms, which could expand prescribing beyond current depression-focused use. The approval also reinforces continuing interest in oral CNS therapeutics that can compete in rapid-symptom-treatment settings where existing options are limited.