Axsome Therapeutics Inc.
Axsome Therapeutics Announces Topline Results from PARADIGM Phase 3 Trial for Solriamfetol in MDD
Summary
On April 1, 2025, Axsome Therapeutics, Inc. announced the topline results from its PARADIGM Phase 3 trial of solriamfetol in major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS). The trial did not meet its primary endpoint of demonstrating a statistically significant change on the Montgomery-Asberg Depression Rating Scale (MADRS) total score in the overall patient population. However, in the subgroup of patients with severe EDS, solriamfetol showed greater improvements in depressive symptoms compared to placebo. Axsome plans to initiate a Phase 3 trial in MDD patients with EDS in 2025. Solriamfetol was safe and well tolerated in the trial.
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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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