Axsome Therapeutics won FDA approval to expand Auvelity’s label to include Alzheimer’s disease agitation, giving the company a second FDA-approved indication for its dextromethorphan-bupropion combination therapy. The approval is aimed at patients with agitation in Alzheimer’s disease, a symptom group Axsome said affects up to three-quarters of patients. The company also positioned Auvelity’s profile as an advantage relative to competitors that carry boxed warnings. With the drug set to launch in June at a wholesale acquisition cost of $1,248 for a 30-day supply, the expanded indication opens a new revenue pathway in a high-need but tightly regulated market.