Axsome Therapeutics(AXSM) Newsfilter·2025-03-25 11:00Core Insights - Axsome Therapeutics announced positive results from the FOCUS Phase 3 trial of solriamfetol for treating ADHD, achieving both primary and key secondary endpoints with statistically significant improvements compared to placebo [1][2][3] Group 1: Trial Results - The trial demonstrated a statistically significant reduction in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score, with mean reductions of 17.7 points for solriamfetol 150 mg versus 14.3 points for placebo, representing a 45% mean reduction from baseline in ADHD symptoms [2][3] - Clinical response, defined as a ≥30% improvement from baseline in the AISRS total score, was achieved by 53.5% of patients on solriamfetol 150 mg compared to 41.3% on placebo at Week 6 [2] - The onset of action for solriamfetol was observed as early as Week 1, with a statistically significant improvement compared to placebo [1][2] Group 2: Safety and Tolerability - Solriamfetol was well tolerated, with a safety profile consistent with previous trials, and no serious adverse events reported [1][4] - Rates of adverse events were dose-dependent, indicating a manageable safety profile for the drug [4] Group 3: Future Development - Axsome Therapeutics plans to initiate a trial for solriamfetol in pediatric patients following the positive results in adults, highlighting the company's commitment to expanding treatment options for ADHD [4][6] - The results from the FOCUS trial provide the first evidence from a multicenter controlled trial regarding the efficacy of solriamfetol in treating ADHD, positioning it as a potential new treatment option [4][6] Group 4: Industry Context - ADHD is a prevalent condition affecting an estimated 15.5 million adults and 7 million children in the U.S., with significant societal costs exceeding $120 billion annually [7] - Solriamfetol is being developed as a treatment for ADHD and other CNS disorders, indicating its potential impact on a large patient population [8][9]