NEW YORK, April 30, 2026
LAxsome Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITY® (dextromethorphan HBr and bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease, marking a major milestone in neuropsychiatric care. AUVELITY becomes a first-in-class treatment for this condition, targeting the NMDA and sigma-1 receptors, and offering a much-needed FDA-approved therapy for one of the most distressing and underserved symptoms of Alzheimer’s disease. The approval details are highlighted in the uploaded PDF
First-in-Class Therapy Addresses Major Unmet Need
Alzheimer’s disease affects more than 7 million Americans, and agitation is reported in up to 76% of patients, often including symptoms such as pacing, restlessness, irritability, verbal aggression, and physical aggression. This condition is one of the most challenging aspects of dementia care, contributing to accelerated cognitive decline, increased caregiver burden, nursing home placement, and higher mortality risk.
AUVELITY® is the first FDA-approved medicine specifically indicated for agitation associated with dementia due to Alzheimer’s disease. Its unique mechanism targets N-methyl-D-aspartate (NMDA) receptors and sigma-1 receptors, helping regulate neurotransmitter pathways involved in agitation symptoms. This differentiated mechanism offers an important alternative to traditional off-label psychiatric medications often used in these patients.
According to Axsome CEO Herriot Tabuteau, MD, the approval represents a major step forward for millions of patients, families, and caregivers who have long faced limited treatment options for this debilitating condition
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Strong Phase 3 Clinical Data Supported FDA Approval
The FDA approval is supported by a comprehensive clinical program that included the Phase 3 ADVANCE-1 and ACCORD-2 studies. In the ADVANCE-1 trial, a 5-week double-blind study, AUVELITY showed statistically significant superiority over placebo in improving agitation symptoms as measured by the Cohen-Mansfield Agitation Inventory (CMAI) total score, meeting the study’s primary endpoint.
The trial also showed significant improvement on the key secondary endpoint using the modified Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC), where a greater proportion of patients were rated as clinically improved.
In the long-term ACCORD-2 study, patients who continued treatment with AUVELITY demonstrated a statistically significant longer time to relapse of agitation symptoms compared to those switched to placebo, highlighting the therapy’s durability and long-term clinical value
Breakthrough Therapy and Priority Review Strengthen Launch
AUVELITY was developed with FDA Breakthrough Therapy Designation and reviewed under Priority Review, reflecting its potential to provide substantial improvement over existing treatment approaches for a serious condition. The therapy also showed a strong safety and tolerability profile, with the most common side effects being dizziness and dyspepsia, while treatment discontinuation due to adverse events remained low and matched placebo rates.. Importantly, AUVELITY was already FDA-approved in 2022 for major depressive disorder (MDD) in adults and has been used by more than 300,000 patients across clinical and real-world settings, strengthening physician familiarity and commercial readiness.
Axsome is also launching the Auvelity OnMySide™ patient support program, which includes affordability assistance, prior authorization support, samples, and access tools for eligible patients starting treatment.
With first-in-class approval, strong Phase 3 validation, and immediate commercial readiness, AUVELITY is positioned to become a transformative treatment for Alzheimer’s disease agitation, significantly improving care options for patients, caregivers, and healthcare providers managing this complex neuropsychiatric condition.
Source: Axsome Therapeutics press release
