Axsome Therapeutics doses first patient in FOCUS-3 phase 3 ADHD trial

• Axsome Therapeutics (NASDAQ:AXSM) has dosed the first patient in the FOCUS-3 Phase 3 trial evaluating solriamfetol for adolescents with ADHD.
• The randomized, double-blind, placebo-controlled study will enroll approximately 468 patients aged 12 to under 18 years.
• The primary endpoint is the change from baseline to week 6 in ADHD-RS-5 total score.

Axsome Therapeutics (NASDAQ:AXSM) announced that the first patient has been dosed in the FOCUS-3 Phase 3 trial of solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents.

The randomized, double-blind, placebo-controlled, multicenter study is designed to enroll approximately 468 patients aged 12 to under 18 years, who will be treated for six weeks.

The primary endpoint is the change from baseline to week 6 in the ADHD Rating Scale-5 (ADHD-RS-5) total score.

This trial represents a key step in Axsome’s efforts to expand solriamfetol’s potential use beyond its current indications into ADHD.

Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor that is currently approved for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea in adults.

Axsome Therapeutics is advancing a pipeline of novel therapies targeting central nervous system disorders with high unmet medical needs, including depression, migraine, and now ADHD in adolescents.

The company continues to execute on its late-stage clinical development programs with the goal of delivering new treatment options to patients.