Recent approval by the Food and Drug Administration (FDA) expands the 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 FDA move marks the first time the agency has approved a drug that is not an antipsychotic for this specific condition. FDA said it initially approved Auvelity in 2022 to treat major depressive disorder in adults.

"This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer's disease," said FDA Commissioner Marty Makary.

The FDA granted breakthrough therapy designation and priority review designation for this action. The approval of Auvelity for agitation associated with dementia due to Alzheimer's disease was granted to Axsome Therapeutics.

Comments or questions? Contact Patrick Connole at pconnole@parkplacelive.com.