Axsome doses first patient in FOCUS-3 Phase 3 ADHD trial
Axsome Therapeutics, Inc. has initiated the FOCUS-3 Phase 3 trial by dosing the first patient to evaluate solriamfetol for adolescents with ADHD. The randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of the drug in approximately 468 patients aged 12 to less than 18 years over a 6-week treatment period.
*this image is generated using AI for illustrative purposes only.
Axsome Therapeutics, Inc. has dosed the first patient in the FOCUS-3 Phase 3 trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder (ADHD). The trial aims to assess the efficacy and safety of the drug in this patient population, addressing a critical gap in care for CNS disorders.
FOCUS-3 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial. Approximately 468 patients aged 12 to less than 18 years with ADHD will be randomized in a 1:1:1 ratio to receive one of two doses of solriamfetol 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.
About Solriamfetol
Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist. It is being developed for the treatment of ADHD, major depressive disorder (MDD) with excessive daytime sleepiness (EDS), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
Trial Design
| Parameter | Details |
|---|---|
| Trial Name | FOCUS-3 |
| Phase | Phase 3 |
| Design | Randomized, double-blind, placebo-controlled, multicenter |
| Participants | Approximately 468 patients aged 12 to <18 years |
| Randomization Ratio | 1:1:1 |
| Treatment Duration | 6 weeks |
| Primary Endpoint | Change from baseline to week 6 in ADHD-RS-5 total score |
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company focused on the treatment of central nervous system (CNS) conditions. The company'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 and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing serious neurological and psychiatric conditions.
What are the potential regulatory challenges Axsome might face when seeking approval for an adolescent ADHD indication?
How could the success of the FOCUS-3 trial impact Axsome's strategy for developing solriamfetol for other CNS disorders like MDD and binge eating disorder?
What competitive advantages does solriamfetol offer over existing ADHD treatments for adolescents, particularly regarding its mechanism of action?
17
Access 50+ Readymade Screeners 
Use 200+ Custom Filters 
Get Full Market Insights 
