# The drug offers a new treatment option for patients with Alzheimer's-related agitation.

*biotech · news · 2026-05-01 · Newsmax*

## Key points

- The FDA has approved Axsome Therapeutics' Auvelity for agitation in Alzheimer's patients.
- Auvelity provides an alternative to antipsychotics, which carry serious safety risks for these patients.
- Up to 70% of U.S. Alzheimer's patients experience agitation, previously lacking a safer treatment option.
- Auvelity is the first FDA-approved drug specifically targeting Alzheimer's-related agitation.

The U.S. Food and Drug Administration has approved Axsome Therapeutics' drug to treat agitation in patients ‌with Alzheimer's ​disease, the company said on Friday. The drug, branded ⁠as Auvelity, offers ​a new treatment option for patients ⁠with Alzheimer's-related agitation, marked by restlessness, aggression and emotional distress. ‌These patients have long ​relied on ‌antipsychotic drugs, which had ‌serious safety risks. Alzheimer's disease, the most common form of dementia, affects ⁠about 7 ‌million people ⁠in the United States. ⁠Agitation occurs ⁠in up to 70% of ‌the patients, contributing to faster cognitive decline, heavier burden on ‌caregivers, ​and ‌higher risk of death.

**Companies:** Axsome Therapeutics
**Countries:** United States

[Read the full story on Newsmax](https://www.newsmax.com/health/health-news/alzheimers-medication-agitation/2026/05/01/id/1254876/)

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