FDA Approves Auvelity for Agitation in Alzheimer’s Disease - Summary - MDSpire
FDA & Government News

FDA Approves Auvelity for Agitation in Alzheimer’s Disease

The oral combination therapy expands treatment options for agitation associated with dementia due to Alzheimer’s disease.

Share

The FDA has approved dextromethorphan hydrobromide and bupropion hydrochloride (Auvelity) for treating agitation linked to Alzheimer's disease, affecting up to 76% of patients. The approval is based on phase 3 trials demonstrating significant improvements in agitation symptoms and clinician-reported benefits. Recommended dosing begins at 30 mg/105 mg once daily, with careful monitoring for side effects and interactions, especially in older adults. Prior to this, the medication received approval for major depressive disorder.

Original Source(s)

FDA Approves Auvelity for Agitation in Alzheimer’s Disease

  • by Kathryn Wighton

  • April 30, 2026

Related Content

Cognition-Affecting Drugs Often Start in Acute Care

Older patients frequently continued these medication classes 1 year after initiation

Model May Reframe Tension-Type Headache

Proposed framework organizes interacting factors into four domains to guide personalized assessment

Switching Anticoagulants After Breakthrough Stroke May Not Improve Outcomes

Registry-based analysis found no short-term advantage to changing therapy following ischemic stroke in patients with atrial fibrillation