FDA approves first non-antipsychotic drug to treat agitation associated with dementia

FDA

30 April 2026 - The US FDA today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. 

The drug is the first FDA approved treatment for this condition that is not an antipsychotic. 

The FDA initially approved Auvelity in 2022 to treat major depressive disorder in adults.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration