Axsome Therapeutics Initiates FOCUS Phase 3 Trial of Solriamfetol for Adult ADHD Treatment

10 July 2023 | Monday | News

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.
Image Source | Public Domain

Image Source | Public Domain

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).

 

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.4,5Approximately 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

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