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2024年1月份 J.P. MORGAN HEALTHC...
若VX-548能在后续研究中取得成功,镇痛药市场将迎来大变革。 主要参考资料: 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...
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2024年1月份 J.P. MORGAN HEALTHC...
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2024年1月份 J.P. MORGAN HEALTHC...
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...
The Phase 3 program will also include a single-arm study evaluating the safety and effectiveness of VX-548 in multiple other types of moderate to severe acute pain. In this study, patients will be treated for up to 14 days. About the VX-548 Phase 2 Study in Neuropathic Pain ...
7/31,Vertex制药公司申请批准其非阿片类镇痛药suzetrigine(VX-548)用于治疗中度至重度急性疼痛的申请已被FDA接受,且获得了优先审查,目标行动日期定为明年1月30日。该公司在4月已向FDA提交了口服选择性NaV1.8疼痛信号抑制剂的滚动申请。 Vertex公司的首席法规与质量官Nia Tatsis指出,由于急性疼痛治疗中的“高未满足需...
and inflammatory pain. With Vx-548 reaching its effective endpoint in Phase II clinical practice, the NAV1.8 target has become a popular target for non addictive analgesics. The EPhys team in ICE has validated patch clamp method for human- and rat-derived NAV1.8 cell lines and action potentials...
Suzetrigine is an oral selective NaV1.8 pain signal inhibitor (formerly known as VX-548). Following the positive Phase 3 results in acute pain announced in January 2024, the Food and Drug Administration (FDA) has granted a rolling New Drug Application (NDA) submission for suzetrigi...
- 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 Designation granted by FDA - ...