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非阿片类创新止痛药HTX-011有望今年上市

2019-01-16 佚名 汉鼎好医友

术后疼痛可能是手术最难捱的问题之一。一些患者对阿片类止痛药心存忌惮,而犹豫不决。近日,FDA接受在研的非阿片类创新止痛药HTX-011的新药申请(NDA),并授予其优先评审资格。HTX-011是固定剂量的局部麻醉药Bupivacaine和抗炎药Meloxicam联合长效缓释剂,被用于术后疼痛管理。HTX-011是目前第一个也是唯一一个被设计专用于手术部位,通过单次给药治疗术后疼痛和炎症的双重作用组

术后疼痛可能是手术最难捱的问题之一。一些患者对阿片类止痛药心存忌惮,而犹豫不决。

近日,FDA接受在研的非阿片类创新止痛药HTX-011的新药申请(NDA),并授予其优先评审资格。

HTX-011是固定剂量的局部麻醉药Bupivacaine和抗炎药Meloxicam联合长效缓释剂,被用于术后疼痛管理。HTX-011是目前第一个也是唯一一个被设计专用于手术部位,通过单次给药治疗术后疼痛和炎症的双重作用组合产品。

HTX-011采用Heron专有的Biochronomer药物输送技术,通过向组织损伤部位持续给药从而显着缓解患者术后疼痛。同时,减少对影响中枢神经系统的镇痛药的需求,如阿片类药物。阿片类药物具有有害副作用、滥用和成瘾的风险。

该药的申请基于五项2期临床试验和三项3期临床试验,接受5种不同手术的1000多名患者参与了该临床试验。HTX-011在五种不同的外科模型中疗效明显优于安慰剂或Bupivacaine组,并于2018年第二季度获得突破性治疗称号。2018年10月HTX-011向FDA提交了新药申请,12月底接受了优先审查。

“减少阿片类药物滥用是大势所趋,但多数患者仍在使用大量阿片类药物治疗术后疼痛。”佛罗里达州医院微创普外科医学主任Jay Redan博士说,“人们迫切需要安全、有效和无成瘾的药物,以减少阿片类药物的使用,改善康复体验。”而HTX-011可显着降低术后(尤其是出院后)经历剧烈疼痛和接受类阿片治疗的患者比例。

据了解,该药有望在年内通过FDA批准。

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    2019-01-18 lhlxtx
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