The P-III (SYMPHONY) trial evaluates the safety & efficacy of AXS-12 (5mg, QD for wk.1. & BID for wks.2-5) vs PBO in narcolepsy patients (n=90). The 1EP of the study was change in frequency of weekly cataplexy attacks
The study depicted 83% vs 66% & 56% vs 31% reduction in weekly cataplexy attacks at wk.5 & 1 with a remission of cataplexy achieved in 33% vs 9.5% & 24% vs 4.5% of patients at wk.5 & 2. Reduction in EDS severity at wk.5 was depicted by a mean reduction on the CGI-S as 1.8 vs 0.9 points whereas cataplexy response & reduction in the number of inadvertent naps was achieved in 57% vs 33% & 54% vs 28% of patients at wk.5
AXS-12 also depicted an improvement in overall narcolepsy severity, patient function & QoL at wk.5
Ref: Axsome Therapeutics | Image: Axsome Therapeutics
Related News:- Axsome Therapeutics Receives FDA’s Orphan Drug Designation for AXS-12 (reboxetine) to Treat Narcolepsy
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