Axsome Therapeutics has dosed the first patient in its Phase 3 FOCUS‑2 trial of solriamfetol in children with ADHD, expanding its pediatric program alongside the ongoing adolescent FOCUS‑3 study.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
Axsome Therapeutics has announced that the first patient has been dosed in the Phase 3 FOCUS-2 clinical trial evaluating solriamfetol for children aged 6 to less than 12 years with attention deficit hyperactivity disorder (ADHD). The milestone follows the previously announced initiation of the FOCUS-3 Phase 3 study in adolescents aged 12 to less than 18 years with ADHD.
First Patient Dosed in Phase 3 FOCUS-2 Trial
The FOCUS-2 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) study is a Phase 3, randomized, double-blind, placebo-controlled, multicentre clinical trial designed to evaluate the efficacy and safety of solriamfetol in children aged 6 years to less than 12 years with ADHD.
Approximately 468 participants will be enrolled and randomized in a 1:1:1 ratio to receive one of two dose levels of solriamfetol or placebo over a six-week treatment period. The study’s primary efficacy endpoint is the change from baseline to Week 6 in the Attention Deficit Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) total score, a validated measure used to assess the severity of ADHD symptoms and treatment response.
ADHD Remains a Major Public Health Challenge
Attention deficit hyperactivity disorder is a chronic neurodevelopmental disorder characterised by persistent patterns of inattention, hyperactivity, and impulsivity that interfere with normal functioning and development. In addition to these core symptoms, many patients experience impairments in executive functioning, including attention, planning, working memory, behavioural inhibition, and problem-solving abilities. In the United States, nearly 7 million children and 15.5 million adults are affected, with symptoms continuing into adulthood for many patients. The disorder also imposes an annual societal economic burden exceeding $120 billion.
Solriamfetol Targets Multiple Neurotransmitter Pathways
Solriamfetol is an investigational central nervous system therapy with a differentiated pharmacological profile. It functions as a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist. Beyond ADHD, solriamfetol is also being developed for major depressive disorder with excessive daytime sleepiness (EDS), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD), reflecting Axsome’s development program across multiple CNS disorders.
Strengthening Pediatric ADHD Development Program
The first patient dosed in the Phase 3 FOCUS-2 trial marks a key advancement in Axsome Therapeutics’ clinical development program for solriamfetol in ADHD. Together with the ongoing FOCUS-3 Phase 3 study in adolescents aged 12 to less than 18 years, the program extends the evaluation of solriamfetol across pediatric ADHD populations. The randomized, placebo-controlled Phase 3 studies are designed to assess the efficacy and safety of solriamfetol in children and adolescents with ADHD and are expected to generate evidence to support the continued clinical development of the investigational therapy.
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About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.