Axsome Therapeutics’ Auvelity expanded its U.S. label to include Alzheimer’s disease agitation, giving the company access to a second major FDA-approved indication for its dextromethorphan–bupropion combination. The approval arrives ahead of a June launch window for the agitation population. The decision adds a new treatment option for a symptom complex that can be common and challenging to manage in Alzheimer’s care, where drug safety considerations and boxed-warning comparisons shape prescribing behavior. Axsome positioned Auvelity’s label as cleaner relative to a key comparator that carries a boxed warning. With agitation potentially affecting a large share of patients, the approval sets up a near-term commercial test for Auvelity’s differentiation versus existing off-label approaches and approved therapies.