FDA Approves Auvelity for Agitation in Alzheimer's Dementia

The Food and Drug Administration (FDA) has approved Auvelity, extended-release tablets containing dextromethorphan hydrobromide and bupropion hydrochloride, for treating agitation associated with dementia due to Alzheimer’s disease in adult patients.

This decision marks Auvelity as the first non-antipsychotic medication approved for this specific indication. Previously, treatment options primarily consisted of antipsychotic drugs, which carry their own set of potential side effects.

Agitation, a common symptom of Alzheimer's disease, manifests in various ways, including restlessness, pacing, verbal outbursts, and resistance to care. The condition can significantly impact both patients and their caregivers. Auvelity offers a new approach to manage this symptom without relying on traditional antipsychotic medications.

The FDA's approval follows a review of clinical trial data evaluating Auvelity's safety and efficacy in patients with dementia and agitation. Further details on the clinical trials are available on the FDA website.