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biotech/news//Medical Xpress
Auvelity was initially approved in 2022 to treat major depressive disorder in adults.
The FDA approved Auvelity for agitation in adults with Alzheimer's-related dementia.
KEY POINTS
Auvelity is the first nonantipsychotic approved for agitation linked to Alzheimer's disease dementia.
Approval followed a five-week trial showing significant improvement over placebo on agitation ratings.
Patients continuing on Auvelity had a longer time to relapse of agitation than those switched to placebo.
Efficacy was demonstrated in two randomized clinical trials supporting the expanded approval.
The U.S. Food and Drug Administration has approved the expanded use of Axsome Therapeutics' Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat adults with agitation associated with dementia due to Alzheimer's disease.
Auvelity was initially approved in 2022 to treat major depressive disorder in adults and is the first nonantipsychotic approved for agitation associated with dementia due to Alzheimer's disease.
The approval was based on a five-week trial in which participants received either Auvelity or a placebo. Those randomly assigned to Auvelity showed a significantly greater change in the primary end point of total score of the Cohen-Mansfield Agitation Inventory based on caregiver reports.
Among those who achieved a response, those who were randomly assigned to continue Auvelity treatment had a significantly longer time to relapse of agitation symptoms versus patients subsequently assigned to receive placebo.
"Auvelity was found to be efficacious for treating agitation in Alzheimer's disease in two randomized trials and now represents an additional option to address one of the most difficult sequelae of the disease, especially as it progresses," Tracy Beth Hoeg, M.D., Ph.D., from the FDA Center for Drug Evaluation and Research, said in a statement.
"We hope this approval will provide meaningful benefit to patients, their families, and caregivers."