Axsome Therapeutics Reports Topline Data of P-III (PARADIGM) Trial of Solriamfetol for Major Depressive Disorder (MDD) regardless of Excessive Daytime Sleepiness (EDS)
Shots:
- Axsome reported topline data of PoC P-III (PARADIGM) trial assessing solriamfetol (300mg) vs PBO in MDD pts with severe EDS (ESS ≥16; n=51) & those without severe EDS (n=295)
- Trial showed no significant MADRS total score change (1EP) in the overall population. However, EDS pts saw depressive symptom improvements across MADRS total score, MADRS anhedonia subscale, MADRS remission (total score ≤10), CGI-S, CGI-I, & PGI-I measures at Wk. 6 while in non-severe EDS pts, no meaningful difference was observed; full data to be presented at future meetings
- Based on findings from EDS subgroup, Axsome has planned to initiate P-III trial in MDD pts with EDS in 2025
Ref: Globenewswire | Image: Axsome
Related News:- Axsome Therapeutics Reports P-III (FOCUS) Trial Data of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD)
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