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.

By
Kathryn Wighton
April 30, 2026
3 min

MDSpire News

Objective:

To report the FDA approval of Auvelity for treating agitation associated with Alzheimer's disease.

Approach:

Key Findings:

Agitation affects up to 76% of Alzheimer's patients.
Dextromethorphan-bupropion significantly improved agitation symptoms in clinical trials.
The treatment has a specific dosing regimen for agitation in Alzheimer's, differing from major depressive disorder.

Interpretation:

The approval of Auvelity provides a new treatment option for managing agitation in Alzheimer's patients, addressing a significant symptom that affects quality of life.

Limitations:

The mechanism of action for agitation treatment remains unclear.
The relapse findings in ACCORD-2 should be interpreted with caution due to prior responder enrollment.

Conclusion:

Auvelity's approval represents a significant advancement in the treatment of agitation in Alzheimer's disease, with specific dosing and safety considerations.