GlobeNewswire·May 1, 2026, 7:15 AM ET

Axsome Therapeutics Hosts AUVELITY® FDA Approval Investor Event Featuring Expert Thought Leader

AXSM

Axsome Therapeutics, Inc. hosted a virtual investor event on May 1, 2026, to discuss the FDA approval of AUVELITY for agitation associated with dementia due to Alzheimer's disease.
The company announced that AUVELITY is the first-in-class treatment for this indication, targeting NMDA & sigma-1 receptors.
Dr. Jeffrey Cummings provided a clinical overview of Alzheimer's disease agitation, while Axsome management detailed anticipated commercial plans.
Agitation affects up to 76% of Alzheimer's patients & is linked to accelerated cognitive decline, increased caregiver burden, & higher mortality risk.
AUVELITY combines dextromethorphan HBr & bupropion HCl, originally approved in 2022 for major depressive disorder.
The drug is protected by a patent estate extending to at least 2043.
A boxed warning highlights risks of suicidal thoughts in children, adolescents, & young adults, prohibiting use in pediatric patients.
Serious side effects include seizures, increased blood pressure, manic episodes, unusual thoughts or behaviors, angle-closure glaucoma, dizziness, serotonin syndrome, & hyponatremia.
AUVELITY is contraindicated for patients with seizure disorders, eating disorders, recent alcohol or benzodiazepine withdrawal, MAOI use, or allergies to its ingredients.
Dosing for Alzheimer's agitation starts at 30 mg/105 mg once daily, increasing to twice daily on Day 8, with a potential maximum dose of 45 mg/105 mg twice daily on Day 15.
Patients are advised to avoid breastfeeding during treatment & for 5 days after the final dose due to drug passage into breast milk.
Axsome Therapeutics maintains a portfolio of CNS treatments including SUNOSI, AUVELITY, & SYMBRAVO for various neurological conditions.