Axsome Therapeutics held a virtual investor event and conference call on May 1 at 8:00 AM Eastern Time to discuss the 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. Dr. Jeffrey Cummings, Chambers-Grundy Professor of Brain Sciences at UNLV Kirk Kerkorian School of Medicine, provided an overview of Alzheimer’s disease agitation, its current treatment landscape, and shared his clinical perspective on AUVELITY, while Axsome management provided information about anticipated commercial plans.
Alzheimer’s disease is the most common form of dementia, affecting more than 7 million people in the United States. Agitation associated with Alzheimer’s dementia is a neuropsychiatric condition reported in up to 76% of patients with the disease and is characterized by emotional distress, verbal and physical aggressiveness, disruptive irritability, and disinhibition. Agitation has been associated with accelerated cognitive decline, increased caregiver burden, and increased mortality risk, and is a leading cause of assisted living or nursing home placement. The exact cause of agitation in the brain is not known but is associated with changes in glutamate and monoamine signaling.
AUVELITY was initially approved by the FDA in 2022 for treating major depressive disorder in adults and is the first and only rapid-acting oral treatment approved with statistically significant improvement in depressive symptoms compared to placebo, starting at one week. AUVELITY is protected by a robust patent estate extending to at least 2043. The most common side effects when treating agitation associated with Alzheimer’s disease include dizziness and indigestion. AUVELITY should not be used on an as-needed basis for this indication and carries important safety warnings including risks of seizures, increased blood pressure, manic episodes in those with bipolar disorder, and unusual thoughts or behaviors.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.globenewswire.com/news-release/2026/05/01/3285840/33090/en/Axsome-Therapeutics-Hosts-AUVELITY-FDA-Approval-Investor-Event-Featuring-Expert-Thought-Leader.html