April 30, 2026
2 min read
Key takeaways:
- Up to 76% of patients with Alzheimer’s disease experience agitation.
- Auvelity is the first drug approved for agitation that is not an antipsychotic.
- Dizziness and dyspepsia were the most common adverse events.
The FDA has approved Auvelity for treating agitation in patients with dementia due to Alzheimer’s disease, Axsome Therapeutics said in a press release.
Up to 76% of patients with Alzheimer’s disease experience agitation, including pacing, restlessness and verbal or physical aggression, according to the release.
Auvelity represents the first non-antipsychotic medication approved for treatment of agitation in Alzheimer’s disease.
“Alzheimer’s disease agitation is associated with accelerated cognitive decline, placement in assisted living and long-term care facilities, and increased mortality risk,” Jeffrey Cummings, MD, ScD, Chambers-Grundy Professor of Brain Sciences at the UNLV Kirk Kerkorian School of Medicine, said in the press release.
“Treatment for agitation associated with Alzheimer’s disease dementia has been a crucial unmet need,” he said. “The approval of Auvelity for this condition has the potential to play an important role in patient care for this challenging and impactful symptom.”
The clinical program that supported this approval included the phase 3 ADVANCE-1 study, which found statistically significant improvement in Cohen-Mansfield Agitation Inventory scores at week 5 with Auvelity (dextromethorphan hydrobromide and buproprion hydrochloride) compared with placebo.
Also, the proportion of patients with at least minimal improvement in modified Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change scores was statistically significantly greater in the treatment group, compared with placebo.
Patients who responded to treatment in ADVANCE-1 then entered the double-blind ACCORD-2 study, which found statistically significantly longer times to relapse in symptom agitation symptoms with treatment at 6 months compared with placebo.
Dizziness and dyspepsia were the most common adverse reactions during ADVANCE-1. Rates of discontinuation due to an adverse event included 1.3% for the treatment and placebo groups alike.
Frank M. Longo
“For patients and caregivers, any progress in Alzheimer’s treatment is meaningful. This milestone highlights the advances being made in addressing the day-to-day realities of the disease,” Frank M. Longo, MD, PhD, cofounder and chairman of the board at PharmatrophiX, said in a prepared statement provided to Healio.
“It reflects the growing momentum in innovative treatments for neurodegenerative diseases and further underscores the continued need for disease-modifying therapies,” Longo said.
The Alzheimer’s Association said in a separate press release that it welcomes the approval, noting that agitation is among the most difficult symptoms of the disease to manage and that it seriously impacts both patients and their families.
Joanne Pike
“For too long, people living with Alzheimer’s disease agitation and their families have had limited options, and the options that existed came with significant risks,” Alzheimer’s Association President and CEO Joanne Pike, DrPH, said in the release.
The Alzheimer’s Association further noted that this is the first approval for an agitation treatment in Alzheimer’s disease that is not an antipsychotic.
“This approval gives patients, caregivers and clinicians an important new tool, one that works through a different mechanism than antipsychotic medications and that can help address a symptom that profoundly affects quality of life,” Pike said.
For more information:
Frank M. Longo, MD, PhD, can be reached at neurology@healio.com.
Sources/Disclosures
Source:
Press Release
Reference:
Disclosures:
Cummings and Longo did not report any relevant financial disclosures at the time of publication. Pike reports employment with the Alzheimer’s Association.
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