Axsome Therapeutics Reports P-III (FOCUS) Trial Data of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD)
Shots:
- Axsome Therapeutics has reported P-III (FOCUS) trial data assessing solriamfetol (150 or 300mg, QD) vs PBO for 6wks. to treat of ADHD adults (n=516) in the US
- Trial met its 1EP, with 150mg showing greater AISRS score reductions vs PBO at Wk. 6 (17.7 vs 14.3 mean point decrease); improvements began at Wk. 1, & a higher clinical response (≥30% AISRS improvement) was observed in the 150mg arm (53.5% vs 41.3%) at Wk. 6
- Overall, solriamfetol achieved 45% mean symptom reduction, with reduced ADHD disease severity (2EP) per CGI-S; 300mg was superior to PBO but was not statistically significant
Ref: Axsome Therapeutic | Image: Axsome Therapeutic
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