Axsome Therapeutics Initiates FOCUS Phase 3 Trial of Solriamfetol for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults

NEW YORK, July 07, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it has dosed the first patient in the FOCUS Phase 3 trial of solriamfetol, an investigational treatment for attention deficit hyperactivity disorder (ADHD) in adults.

FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of ADHD in adults. Approximately 450 patients will be randomized in a 1:1:1 ratio to receive solriamfetol (150 mg or 300 mg) or placebo for 6 weeks. The primary endpoint will be change in the Adult ADHD Investigator Symptom Report Scale (AISRS).

About Attention Deficit Hyperactivity Disorder (ADHD)

ADHD is a chronic neurobiological and developmental disorder characterized by a persistent pattern of inattention, hyperactivity or impulsivity, that interferes with functioning or development.¹ Impairments in cognition are apparent in attention, planning and problem solving, working memory, and behavioral inhibition.^2,3 An estimated 11.4 million adults in the U.S. are diagnosed with ADHD, and the condition affects an estimated 5% of children and adolescents.^4,5 Approximately two-thirds or more of children with ADHD continue to have symptoms and challenges in adulthood.⁶ The total annual societal excess costs associated with adult ADHD in the U.S. have been estimated at $122.8 billion.⁷

About Solriamfetol

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor. In vitro studies have also shown that solriamfetol has agonist activity at trace amine-associated receptor 1 (TAAR1) and 5HT_1a receptors. Solriamfetol is not approved by the FDA for the treatment of ADHD.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.