The 1st trial evaluates the safety & efficacy of VX-548 in patients following abdominoplasty (n=1,118) & bunionectomy (n=1,073) surgery. 1EP was SPID48 vs PBO, 1st Key 2EP was SPID48 vs HB/APAP & time to ≥2-point reduction in NPRS from baseline vs. PBO was the 2nd key 2EP
Results depicted an LS mean SPID48 vs PBO of 118.4 vs 70.1 & 99.9 vs 70.6, LS mean of SPID48 vs HB/APAP of 118.4 vs 111.8 & 99.9 vs 120.1 & median time to reduction vs PBO of 119 vs 480 & 240 vs 480
The 2nd trial evaluates the safety, efficacy & tolerability of VX-548 in patients (n=256) with a broad range of surgical & non-surgical pain conditions with results depicting VX-548 to be generally safe & well tolerated. NDA submission to the US FDA is expected by mid-2024
Ref: Vertex | Image: Vertex
Related News:- Vertex Reports Results of VX-548 in the Two P-II Proof-of-Concept Studies for the Treatment of Acute Pain
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