二十年来首款！福泰制药非阿片类急性镇痛新药III期研究成功

医药魔方02-01

1月30日，Vertex Pharmaceuticals（福泰制药）公布了选择性NaV1.8抑制剂VX-548治疗中至重度急性疼痛的III期项目的积极结果。该III期项目包括3项III期研究（VX22-548-104、VX22-548-105和VX22-548-107）。VX22-548-104和VX22-548-105是两项随机、双盲、安慰剂对照、关键临床试验，其中前者针对的人群为拇外翻矫正术...

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Phase III study of Futai Pharmaceutical's new non-opioid acute analgesic drug was successful","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"VRTX":1,"III":1},"content_text":"1月30日，Vertex Pharmaceuticals（福泰制药）公布了选择性NaV1.8抑制剂VX-548治疗中至重度急性疼痛的III期项目的积极结果。该III期项目包括3项III期研究（VX22-548-104、VX22-548-105和VX22-548-107）。VX22-548-104和VX22-548-105是两项随机、双盲、安慰剂对照、关键临床试验，其中前者针对的人群为拇外翻矫正术患者，后者针对的人群则是腹壁整形术患者；VX22-548-107是一项单臂临床试验，招募的人群包括手术和非手术疼痛患者。在104和105研究中，相较于安慰剂组，VX-548组患者在主要终点0-48小时疼痛强度时间加权总和（SPID48）方面有统计学意义的改善，表现为VX-548组患者第48小时的数值疼痛评定量表（NPRS）评分相较基线有临床意义的下降。在拇外翻矫正术患者中，VX-548与安慰剂组之间的SPID48 LS均值为29.3 (95% CI: 14.0，44.6；P=0.0002）；而在腹壁整形术患者中，VX-548组和安慰剂之间的SPID48最小二乘均值（LS均值）为48.4 (95% CI: 33.6，63.1；P<0.0001）。不过，104和105研究均未达到VX-548在SPID48方面优效于双酒石酸氢可酮/对乙酰氨基酚（HB/APAP）的关键次要终点。具体而言，在拇外翻矫正术患者中，VX-548组和HB/APAP组的LS均值为-20.2（95% CI：-32.7，-7.7；P=0.0016）；而在腹壁整形术患者中，VX-548组和HB/APAP组的LS均值为6.6 (95% CI：-5.4，18.7；P=0.2781）。两项研究的另一个关键次要终点——有意义的疼痛缓解时间（即与安慰剂组相比，NPRS评分较基线降低≥2分的时间）顺利达到。两组安慰剂组患者达到有意义疼痛缓解的中位时间为8小时，而拇外翻矫正术和腹壁整形术患者的VX-548组的相应数据分别为4小时（P=0.0016）和2小时（P<0.0001）。在107研究中，通过患者整体评估（PGA）衡量治疗效果，83.2%的患者将VX-548评为治疗疼痛良好、非常好或优秀。在所有III期研究中，VX-548均表现出了良好的安全性和耐受性。大多数不良事件（AE）为轻至中度，无与VX-548相关的严重不良事件（SAE）。VX-548组不良事件发生率低于安慰剂组（腹壁整形术：50.0% vs 56.3%，拇外翻矫正术：31.0% vs 35.2%）。加州大学圣地亚哥分校急诊医学和疼痛医学助理医师、Vertex急性疼痛指导委员会成员Jessica Oswald,M.D.,M.P.H.说：“作为一名治疗疼痛多年的医生，我深知临床迫切需要全新、有效和安全的治疗方案。这3项III期研究的安全性和有效性结果令人印象深刻，并证明了VX-548改变疼痛管理的潜力。我期待这款20多年来首个急性疼痛治疗药物能够作为阿片类药物的替代品，帮助数以百万计的急性疼痛患者。”Copyright © 2024 PHARMCUBE. 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