FDA Expands Auvelity Approval To Treat Agitation In Alzheimer's Patients
The FDA on Tuesday, May 12, 2026, expanded approval of Auvelity to treat agitation tied to Alzheimer's dementia in adults, making it the first non-antipsychotic option cleared for that symptom.[1]
Auvelity was first cleared in 2022 to treat major depressive disorder, and regulators said two randomized trials supported the new indication.[1] One trial measured efficacy over five weeks and a relapse-prevention study found a longer time to agitation relapse for people who continued the drug.[1]
The FDA warned of side effects including dizziness, gastrointestinal upset, seizures, elevated blood pressure, mania in susceptible patients, and increased suicidal thoughts in younger adults.[1] The approval gives clinicians a new prescription option for managing Alzheimer's-related agitation, but safety monitoring will be important as the medicine is used more widely.
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📌 Key Facts
- On May 12, 2026, the FDA announced expanded approval of Auvelity to treat agitation associated with Alzheimer’s dementia in adults.
- Auvelity, first approved in 2022 for major depressive disorder, is now the first non-antipsychotic drug cleared for Alzheimer’s-related agitation.
- Two randomized trials supported the decision, including a five-week efficacy trial and a relapse-prevention study showing longer time to agitation relapse for those continuing the drug.
- The FDA warns of potential side effects including dizziness, gastrointestinal upset, seizures, elevated blood pressure, mania in susceptible patients, and increased suicidal thoughts in younger adults.
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