Axsome Therapeutics Inc.
Axsome Therapeutics Announces Successful Phase 3 Clinical Trial Results for AXS-05 in Alzheimer's Disease Agitation
Summary
Axsome Therapeutics, Inc. announced the successful completion and results of its Phase 3 clinical program for AXS-05, a novel oral investigational drug for treating Alzheimer's disease agitation. The ACCORD-2 trial achieved its primary endpoint, statistically significantly delaying the time to relapse of agitation (p=0.001) and meeting the key secondary endpoint (p=0.001). Although the ADVANCE-2 trial did not reach statistical significance for its primary endpoint, the results numerically favored AXS-05 over placebo. Long-term safety trials showed AXS-05 was well tolerated, with no increased risk of falls, cognitive decline, or sedation. The company plans to submit a New Drug Application to the FDA in the second half of 2025.
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About Axsome Therapeutics Inc.
Axsome Therapeutics Inc. specializes in the development and commercialization of transformative therapies for central nervous system (CNS) disorders. The company's focus is on addressing unmet medical needs in the fields of depression, migraines, and agitation associated with Alzheimer's disease, among other CNS conditions. Axsome's robust pipeline includes both clinical and preclinical stage compounds, highlighting a commitment to innovation and efficacy. By utilizing novel mechanisms of action, their product candidates aim to offer significant advantages over existing treatments. Axsome Therapeutics plays a crucial role in the pharmaceutical and healthcare sectors, helping reshape treatment paradigms for complex and challenging CNS disorders. Through strategic collaborations and leveraging cutting-edge research methods, the company seeks to provide effective healthcare solutions and improve quality of life for patients globally. Established on a vision to impact lives positively, Axsome continues to advance its clinical programs and regulatory approvals, thereby reinforcing its position in the biotechnology industry.
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