The Phase 3 program will consist of two randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of VX-548 (100 mg first dose, followed by 50 mg every 12 hours) for acute pain after bunionectomy or abdominoplasty. The primary endpoint in both studies...
Vertex并未停止Nav1.8抑制剂的开发。根据Vertex最新公开资料,一方面在着手拓展VX-548新的适应症--糖尿病周围神经病变(DPN,Phase II,突破性疗法);腰骶神经根病(LSR,Phase II);另一方面Vertex也在积极布局第三代的Nav1.8抑制剂VX-993以及VX973已经开始了临床I期的研究。VX-993/973会在药效和PK等方面进一步改善。在...
1、https://news.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-phase-2-study-vx-548-treatment. 2、《“3亿疼痛患者,4000亿市场”,一文深度了解止痛药行业》头豹,?2023-11-17. 3、https://www.orion.fi/en/...
VX-548, in the treatment of moderate-to-severe acute pain. The Phase 3 program included two randomized, double-blind, placebo-controlled, pivotal trials, one following abdominoplasty surgery and one
METHODSAfter establishing the selectivity of VX-548 forNaV1.8inhibition in vitro, we conducted two phase 2 trials involving participants with acute pain after abdominoplasty or bunionectomy. In the abdominoplasty trial, participants were randomly assigned in a 1:1:1:1 ratio to receive one of th...
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Executive Vice President,Global Medicines Developmentand Medical Affairs, and Chief Medical Officer atVertex. “Our Phase 3 trials for VX-548 are well underway, and we look forward to the potential of bringing an effective, non-opioid therapeutic option to patients suffering from moderate ...
Vertex Pharmaceuticals Incorporated today announced that it has begun a Phase 2 proof-of-concept (POC) study in acute pain following bunionectomy surgery with the selective NaV1.8 inhibitor VX-548 and that it expects to commence a second Phase 2 study in
[1] Vertex Announces Publication of VX-548 Positive Phase 2, Proof-of-Concept Results in New England Journal of Medicine. Retrieved August 3, 2023 from https://news.vrtx.com/news-releases/news-release-details/vertex-announces-publication-vx-548-positive-phase-2-proof ...
Vertex Advances VX-548 in Acute and Neuropathic Pain July 22, 2022 - VX-548 advances into pivotal development for people with acute pain; Phase 3 program to initiate in Q4 2022 - - Phase 2 dose-ranging trial in neuropathic pain expected to initiate by year end - -Breakthrough Therapy ...