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Axsome Therapeutics Initiates FOCUS-3 Phase 3 Trial of Solriamfetol in Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)

AXSM
  • Axsome Therapeutics announced that the first patient has been dosed in the FOCUS-3 Phase 3 trial evaluating solriamfetol for adolescents with ADHD.
  • The FOCUS-3 trial is a randomized, double-blind, placebo-controlled, multicenter study for patients aged 12 to less than 18 years.
  • Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of two solriamfetol doses or placebo for 6 weeks.
  • The primary endpoint is the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.
  • Solriamfetol acts as a dopamine & norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, & 5-HT 1A agonist.
  • Axsome Therapeutics is developing solriamfetol for ADHD, major depressive disorder with excessive daytime sleepiness, binge eating disorder, & excessive sleepiness associated with shift work disorder.
  • ADHD affects an estimated 15.5 million adults & 7 million children in the U.S., with over two-thirds of children experiencing symptoms into adulthood.
  • The total annual societal excess cost associated with adult ADHD in the U.S. is estimated at over $120 billion.
  • Axsome's portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer's disease, excessive daytime sleepiness associated with narcolepsy & obstructive sleep apnea, & migraine.
  • The press release contains forward-looking statements regarding clinical trial success, regulatory approvals, & commercialization risks.