Axsome Therapeutics’ AXS-05 receives FDA Priority Review for treating agitation in Alzheimer’s disease, addressing a major unmet need for patients and caregivers.
Written By: Pharmacally Medical News Desk
Axsome Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to its supplemental New Drug Application (sNDA) for AXS-05 for the treatment of agitation associated with Alzheimer’s disease. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026, meaning a regulatory decision is expected by that date.
Priority Review is a designation the FDA uses to accelerate the review of applications that could offer significant advances in safety or effectiveness for serious conditions compared with standard therapies. Under this designation, the review timeline is shortened to a goal of six months rather than the typical ten months.
“We are very pleased the FDA has accepted and granted priority review to our supplemental NDA for AXS-05 for the treatment of Alzheimer’s disease agitation,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Up to 76% of people with Alzheimer’s disease experience agitation, representing a significant unmet medical need for patients and their caregivers, and currently there is a dearth of approved treatments. We look forward to continuing to work with the FDA for the remainder of the review.”
Clinical Context
Agitation is a common and disruptive symptom in Alzheimer’s disease, occurring in up to 76 percent of patients. It includes emotional distress, irritability, aggression, and other behavioral disturbances that can worsen cognitive decline and significantly increase caregiver burden. Approved treatments for agitation in Alzheimer’s remain limited, creating a substantial unmet need.
AXS-05 is an investigational oral therapy composed of dextromethorphan hydrobromide and bupropion hydrochloride. The drug’s mechanism combines an NMDA receptor antagonist and sigma-1 receptor agonist action from dextromethorphan with the norepinephrine and dopamine reuptake inhibition of bupropion, which also boosts dextromethorphan’s bioavailability. Axsome’s proprietary metabolic inhibition technology supports this delivery.
AXS-05 is already approved in the United States as Auvelity for the treatment of major depressive disorder in adults, but it is not yet approved for Alzheimer’s agitation. The supplemental application reflects data from a comprehensive clinical program, including four randomized, double-blind, controlled Phase 3 trials and a long-term safety study.
Regulatory History and Designations
In addition to the current Priority Review designation, the FDA previously awarded AXS-05 Breakthrough Therapy designation for Alzheimer’s disease agitation in June 2020. That pathway is intended to expedite development and review for drugs showing early evidence of substantial improvement over available treatments.
A Priority Review status highlights the FDA’s recognition that AXS-05 could meaningfully improve care options if approved. This is especially significant given the high clinical burden of agitation symptoms and the scarcity of approved therapies.
Axsome will continue to work with the FDA through the review process leading up to the April 30, 2026 action date. Should the agency approve the application, AXS-05 could become one of the few available therapies specifically indicated to treat agitation in Alzheimer’s disease, offering a new option for clinicians, patients, and caregivers.
Background on Alzheimer’s Disease Agitation
Alzheimer’s disease is the most common form of dementia and affects millions of people worldwide. Agitation symptoms are linked to faster cognitive decline, earlier nursing home placement, increased mortality, and marked caregiver stress. A therapy that can safely reduce these symptoms may help improve both patient outcomes and quality of life for caregivers.
References
Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation, 31 December 2025, https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-acceptance-and-priority-0