Axsome registers Phase 3 long-term safety study of Sunosi in pediatric ADHD
Axsome Therapeutics has listed a new Phase 3 trial tracking long-term safety of solriamfetol in children and adolescents with ADHD, enrolling by invitation as of August 2026.
Axsome Therapeutics posted one new pediatric trial record for its ADHD program during the week.
- Axsome registered a Phase 3, open-label trial (NCT07773883, sponsor ID SOL-ADHD-303) tracking long-term safety of solriamfetol in children and adolescents with ADHD1. The study is enrolling by invitation, with an actual start date of August 6, 2026 and estimated primary and study completion in December 20271. Participants are drawn from those who already finished the earlier Study SOL-ADHD-302 ("FOCUS-2") or Study SOL-ADHD-304 ("FOCUS-3")1, and will be grouped into age-based cohorts and dosed with solriamfetol once daily for as long as 52 weeks1. The trial plans to enroll 300 participants1 across three U.S. sites in Alabama, Florida, and Tennessee1.
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