Axsome Therapeutics Reports Results for AXS-12 in P-III Trial for the Treatment of Narcolepsy
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- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
