Axsome Therapeutics Initiates FOCUS Phase 3 Trial of Solriamfetol for the Treatment of 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
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 5HT1a receptors. Solriamfetol is not approved by the FDA for the treatment of ADHD.
About
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain
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Investors:
Chief Operating Officer
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com
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Director, Corporate Communications
Tel: 929-837-1065
Email: dopland@axsome.com
www.axsome.com
References:
American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders, 5 ed.,Arlington, VA :American Psychiatric Publishing , 2013.T. E. Brown , "ADD/ADHD and impaired executive function in clinical practice," Current Psychiatry Reports, vol. 10, p. 407–411, 2008. doi. 10.1037/pne0000271E. Nestler ,S. Hyman andR. Malenka , Molecular Neuropharmacology: AFoundation for Clinical Neuroscience , Second Edition, 2nd edition ed.,New York : McGraw-Hill Professional, 2008.- Faraone, S., Asherson, P., Banaschewski, T. et al. Attention-deficit/hyperactivity disorder. Nat Rev Dis Primers 1, 15020 (2015). https://doi.org/10.1038/nrdp.2015.20
- Kessler RC, et al. The prevalence and correlates of adult ADHD in
the United States : results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Apr;163(4):716-23. doi: 10.1176/ajp.2006.163.4.716 - Sibley, MH et al. Variable Patterns of Remission From ADHD in the Multimodal Treatment Study of ADHD. Am J Psychiatry. 2022 Feb;179(2):142-151. doi: 10.1176/appi.ajp.2021.21010032.
- Schein J, et al. Economic burden of attention-deficit/hyperactivity disorder among adults in
the United States : a societal perspective. JMCP. 2022. 28:2, 168-179. doi: 10.18553/jmcp.2021.21290

Source: Axsome Therapeutics, Inc.