FDA Approves Auvelity for Alzheimer’s Agitation, First Non-Antipsychotic Option Since 2022 Debut
Updated
Updated · Fox News · May 12
FDA Approves Auvelity for Alzheimer’s Agitation, First Non-Antipsychotic Option Since 2022 Debut
7 articles · Updated · Fox News · May 12
Auvelity won FDA clearance to treat agitation in Alzheimer’s disease, giving patients the first non-antipsychotic drug option for a symptom the agency said can severely disrupt patients and caregivers.
Two randomized trials supported the decision: a 5-week study found the drug significantly improved agitated behaviors, and a relapse trial showed patients who stayed on Auvelity went longer before symptoms returned than those switched to placebo.
Axsome Therapeutics’ drug was first approved in 2022 for major depressive disorder and is delivered as a rapid-onset extended-release tablet.
FDA told prescribers to monitor blood pressure, review bipolar history and check for other bupropion- or dextromethorphan-containing medicines; listed risks include seizures, hypertension, mania and suicidal thoughts in younger adults.
Will a new pill for Alzheimer's agitation overshadow crucial non-drug care strategies?
Can families truly afford this breakthrough drug, or will high costs limit its impact?
Auvelity Approved as First Non-Antipsychotic for Alzheimer’s Agitation: Clinical Efficacy, Safety, and Access
Overview
On April 30, 2026, the FDA approved Auvelity as the first non-antipsychotic treatment for agitation in Alzheimer’s disease. This approval is based on strong evidence from four late-stage clinical trials, which showed that Auvelity helps delay relapse and reduces the worsening of symptoms compared to placebo. Agitation is common in Alzheimer’s patients and can seriously affect their quality of life and speed up cognitive decline. With Auvelity, patients and caregivers now have a new option to manage this challenging symptom, marking a major step forward in Alzheimer’s care.