Suzetrigine:A novel non-opioid analgesic for the treatment of moder-ate-to-severe acute pain in adults

VernacularTitle:用于治疗成人术后急性中重度疼痛的新型非阿片镇痛药
Author: Jie TIAN ¹ ; Sheng JIANG ; Huili CHANG
Author Information

1. 广州医科大学药学院,广州 510000,广东;广州医科大学附属清远医院(清远市人民医院)药学部,清远 511500,广东
Publication Type:Journal Article
Keywords: Suzetrigine; sodium channel block-ers; acute pain; analgesics
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(10):1319-1325
CountryChina
Language:Chinese
Abstract: Suzetrigine is the first approved selec-tive Nav1.8 channel inhibitor.On January 30,2025,the U.S.FDA approved Suzetrigine for the oral treatment of moderate to severe acute pain.In two phase Ⅲ clinical trials(NAVIGATE-1 and NAVIGATE-2),Suzetrigine demonstrated statistically significant improvements in the primary efficacy endpoint,time-weighted sum of pain intensity differences over 48 hours(SPID48),compared with placebo.The least squares mean differences were 29.3(95％CI:14.0-44.6;P=0.000 2)and 48.4(95％CI:33.6-63.1;P＜0.000 1),respectively,confirming its robust analgesic efficacy.Furthermore,owing to its high selectivity for Nav1.8,Suzetrigine exhibited favor-able safety and tolerability profiles,with notably lower incidences of nausea,vomiting,and drug de-pendence compared to conventional opioid analge-sics,underscoring its substantial clinical value.