Axsome Therapeutics announced FDA approval of AUVELITY (dextromethorphan HBr and bupropion HCl) for treating agitation associated with dementia due to Alzheimer’s disease. AUVELITY is a first-in-class treatment targeting NMDA and sigma-1 receptors and was developed with FDA Breakthrough Therapy designation and evaluated under Priority Review. The company plans to host a webcast on May 1 at 8:00 AM Eastern Time to discuss the approval.
Safety and tolerability of AUVELITY for agitation associated with Alzheimer’s dementia were established through short-term and long-term trials. In the ADVANCE-1 trial, the most common adverse reactions with incidence of 5% or greater for AUVELITY and occurring more than twice as frequently as placebo were dizziness and dyspepsia. Only 1.3% of patients discontinued AUVELITY due to an adverse event, matching the placebo discontinuation rate. To date, AUVELITY has been administered to more than 300,000 patients in clinical and real-world settings.
AUVELITY was previously approved for major depressive disorder in adults, another indication developed with FDA Breakthrough Therapy designation and Priority Review evaluation. The medication is available as 30 mg dextromethorphan/105 mg bupropion and 45 mg dextromethorphan/105 mg bupropion tablets. When treating major depressive disorder, the most common side effects include dizziness, headache, diarrhea, drowsiness, dry mouth, sexual function problems, and excessive sweating.
Important safety considerations include a boxed warning about potential increases in suicidal thoughts and actions in children, adolescents, and young adults, particularly within the first few months of treatment. The medication may cause serious side effects including seizures, increased blood pressure, manic episodes in those with bipolar disorder, unusual thoughts or behaviors, eye problems, dizziness, and serotonin syndrome when combined with certain medications. AUVELITY should not be used on an as-needed basis for agitation associated with Alzheimer’s dementia.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.benzinga.com/pressreleases/26/04/g52187283/axsome-therapeutics-announces-fda-approval-of-auvelity-dextromethorphan-hbr-and-bupropion-hcl-for-