Vertex Reports Results of VX-548 in the Two P-II Proof-of-Concept Studies for the Treatment of Acute Pain
- The 2 P-II POC studies evaluate VX-548 (selective NaV1.8 inhibitor) vs PBO in 274 & 303 patients with acute pain, following abdominoplasty surgery or bunionectomy surge. The study also included HB/APAP (5mg/325mg, PO, q6h over 42hrs.) to support the evaluation of the VX-548 treatment effect
- The trials met its 1EPs in both acute pain studies i.e., improvement in SPID48 at the high dose @48hrs. was well tolerated in both studies, fewer patients discontinued treatment in the mid & high-dose VX-548 or HB/APAP reference arm, no patients discontinued treatment due to AEs & no patients had SAEs
- The company plans to advance VX-548 into pivotal development in H2’22, following discussions with regulators
Ref: Vertex | Image: Wikipedia
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