Axsome Therapeutics has dosed the first patient in its Phase 3 FOCUS-3 clinical trial evaluating solriamfetol as a potential treatment for adolescents with Attention Deficit Hyperactivity Disorder (ADHD), marking a milestone in the development of the investigational therapy for the neurodevelopmental disorder.

The FOCUS-3 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) study is a randomised, double-blind, placebo-controlled, multicentre Phase 3 trial designed to assess the efficacy and safety of solriamfetol in adolescents aged 12 to under 18 years diagnosed with ADHD.

The trial is expected to enrol approximately 468 participants, who will be randomly assigned in a 1:1:1 ratio to receive one of two doses of solriamfetol or a placebo over a six-week treatment period. The primary endpoint will evaluate the change from baseline to week six in the ADHD Rating Scale total score.

Solriamfetol is being investigated as a potential new treatment option for adolescents with ADHD, a chronic neurodevelopmental disorder characterised by persistent patterns of inattention, hyperactivity and impulsivity that can significantly affect academic performance, daily functioning and overall development.

According to Axsome Therapeutics, ADHD is also associated with impairments in attention, planning, problem-solving, working memory and behavioural inhibition. In the United States, an estimated 15.5 million adults and 7 million children are affected by the condition, with symptoms persisting into adulthood for more than two-thirds of individuals diagnosed during childhood.

The company noted that ADHD also imposes a substantial economic burden, with the annual societal cost associated with adult ADHD in the United States estimated to exceed USD 120 billion.

The initiation of patient dosing in the FOCUS-3 trial represents an important step in Axsome Therapeutics' clinical development programme aimed at expanding treatment options for central nervous system disorders, including ADHD.