Axsome’s Sunosi Shows Promise in Phase III ADHD Trial

Axsome Therapeutics’ Phase III Focus trial (NCT05972044) investigating Sunosi (solriamfetol) for ADHD has met both primary and secondary endpoints, showing a 45% reduction in symptoms.

Key Findings:

• 53.5% of Sunosi 150mg patients achieved a ≥30% AISRS symptom reduction vs. 41% in placebo.
• 17.7-point mean reduction in Adult ADHD Investigator Symptom Rating Scale (AISRS) (vs. 14.3 points for placebo).
• Significant reductions in overall ADHD severity using Clinical Global Impression of Severity (CGI-S).
• 516 adults randomized to Sunosi 150mg, 300mg, or placebo for 6 weeks.
• Sunosi 300mg showed similar improvements, but results were not statistically significant.

Market & Competition:

• Currently approved for narcolepsy and sleep apnea, generating $90M in 2023 (GlobalData).
• ADHD market projected to decline from $11.9B (2022) to $10.9B (2032).
• Innosphere Engineering’s Novostim 2 begins clinical trial recruitment for ADHD treatment.

Sunosi’s success in ADHD could lead to expanded market approval, providing a non-stimulant alternative to existing treatments.

31-03-2025