The FDA has approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation associated with dementia due to Alzheimer’s disease in adults.
Auvelity is the first FDA-approved treatment for this condition that is not an antipsychotic, according to an April 30 agency news release. The FDA granted breakthrough therapy and priority review designations for the approval, which was awarded to Axsome Therapeutics. The drug was initially approved in 2022 to treat major depressive disorder in adults.
The approval was supported by two randomized trials. In a five-week study, patients treated with Auvelity showed greater improvement in agitation symptoms compared to placebo based on the Cohen-Mansfield Agitation Inventory. In a second withdrawal study, patients who continued treatment had a longer time to relapse than those switched to placebo.
Common side effects include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction and uncontrolled sweating. The drug also carries a boxed warning for increased risk of suicidal thoughts and behaviors in adolescents and young adults taking antidepressants.
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