Exploring Solriamfetol: Axsome Therapeutics' Phase 3 Trial for Adolescent ADHD Treatment
Axsome Therapeutics Inc. has initiated the FOCUS-3 Phase 3 trial to evaluate solriamfetol for adolescents with attention deficit hyperactivity disorder (ADHD). The trial aims to determine the efficacy and safety of solriamfetol in adolescents aged 12 to less than 18 years with ADHD. Approximately 468 patients will be enrolled in the study and randomized to receive either solriamfetol or a placebo for six weeks. The primary endpoint of the trial is the change in the ADHD Rating Scale total score from baseline to week six.
Solriamfetol is a medication that acts as a dopamine and norepinephrine reuptake inhibitor, TAAR1 agonist, and 5-HT1A agonist. Axsome Therapeutics is developing solriamfetol for the treatment of ADHD, major depressive disorder with excessive daytime sleepiness, binge eating disorder, and excessive sleepiness associated with shift work disorder. ADHD affects an estimated 15.5 million adults and 7 million children in the U.S., with a significant number of children continuing to experience symptoms into adulthood.
Axsome Therapeutics is a biopharmaceutical company specializing in central nervous system conditions. The company has received FDA approval for treatments targeting major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness linked to narcolepsy and obstructive sleep apnea, and migraine. Despite not yet achieving profitability, Axsome Therapeutics has shown strong performance in the market, delivering a 131% return over the past year and being valued at $12.2 billion.
Recent developments for Axsome Therapeutics include positive sales outlooks for its product Auvelity, particularly in major depression and Alzheimer’s agitation, with potential peak sales exceeding $6 billion. Analysts from Jefferies, TD Cowen, and H.C. Wainwright have raised their price targets for the company, highlighting the growth potential of its products and pipeline. Axsome also presented data on its narcolepsy treatments at the SLEEP 2026 conference, demonstrating its ongoing research efforts and strategic advancements in the pharmaceutical sector.
Investors can access comprehensive analysis of Axsome Therapeutics, including financial health scores and ProTips, on the InvestingPro platform. The stock is currently trading below its Fair Value, indicating potential upside for investors. With the company's promising pipeline and strategic developments, Axsome Therapeutics continues to show potential in the pharmaceutical industry.