Axsome Advances Solriamfetol into Phase 3 Trials for Pediatric ADHD
Event summary
- Axsome dosed the first patient in its FOCUS-2 Phase 3 trial of solriamfetol for children aged 6–12 with ADHD.
- The trial will enroll ~468 patients across two dose groups and a placebo arm, with primary endpoint data expected by mid-2027.
- FOCUS-2 complements the ongoing FOCUS-3 trial in adolescents (ages 12–17) initiated earlier this year.
- Solriamfetol is a DNRI/TAAR1 agonist also under development for MDD, BED, and shift work disorder.
The big picture
Axsome's parallel trials position solriamfetol as a potential multi-indication asset in CNS disorders, targeting a $120B+ adult ADHD market. The pediatric focus addresses an unmet need where stimulant tolerability remains a challenge. Success could validate Axsome's platform strategy of repurposing existing compounds for novel indications.
What we're watching
- Execution Risk
- Whether Axsome can maintain momentum across parallel pediatric and adolescent ADHD trials without resource strain.
- Regulatory Pathways
- The pace at which FDA may evaluate solriamfetol's expanded indications, given its novel mechanism of action.
- Market Differentiation
- How solriamfetol's DNRI/TAAR1 profile will compete against established ADHD treatments like stimulants and non-stimulant alternatives.