Axsome Therapeutics Inc.
Axsome Therapeutics Announces Successful Phase 3 Trial Results for Solriamfetol in ADHD Treatment
Summary
On March 25, 2025, Axsome Therapeutics, Inc. announced that its FOCUS Phase 3 trial for solriamfetol in treating attention deficit hyperactivity disorder (ADHD) achieved its primary and key secondary endpoints. The trial demonstrated substantial and statistically significant improvements in ADHD symptoms and disease severity with solriamfetol compared to placebo. The study, involving 516 adult patients with ADHD, showed a 45% mean reduction in ADHD symptoms at Week 6 with solriamfetol 150 mg. Solriamfetol was also found to have a favorable safety and tolerability profile, with no serious adverse events reported. Axsome plans to initiate a trial in pediatric patients this year.
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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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