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Axsome Therapeutics Initiates FOCUS-2 Phase 3 Trial of Solriamfetol in Children with Attention Deficit Hyperactivity Disorder (ADHD)

AXSM
  • Axsome Therapeutics dosed the first patient in the FOCUS-2 Phase 3 trial evaluating solriamfetol for children with ADHD.
  • The FOCUS-2 trial targets children aged 6 to less than 12 years & will randomize approximately 468 patients in a 1:1:1 ratio to receive 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.
  • This study complements the recently announced FOCUS-3 Phase 3 trial of solriamfetol in adolescents aged 12 to less than 18 years.
  • Solriamfetol functions as a dopamine & norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, & 5-HT 1A agonist.
  • ADHD affects an estimated 7 million children & 15.5 million adults in the U.S., with over two-thirds of children retaining symptoms into adulthood.
  • Axsome Therapeutics holds 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.