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康哲药业(00867.HK)创新药地西泮鼻喷雾剂中国注册性试验全部受试者完成首次给药
格隆汇 10-21 09:58

2020年10月21日,康哲药业(00867.HK)重磅创新药地西泮鼻喷雾剂的中国注册性桥接试验——比较PK研究在湖南省益阳市中心医院全部受试者完成首次给药,这是该产品中国注册上市进程中的重要里程碑事件。

该研究为单中心、随机、开放、两制剂、两周期、双交叉的比较药代动力学研究(“比较PK研究”),共入组24位健康受试者,主要目的为考察空腹条件下地西泮鼻喷雾剂与地西泮注射液在健康受试者体内的药动学特征及生物利用度。根据中国NMPA签发的临床试验通知书要求,康哲药业需开展该项注册临床研究进行桥接以支持上市,并在递交NDA的同时提交上市后进一步验证该产品疗效及安全性的临床研究计划。

地西泮鼻喷雾剂

居家便捷、快速起效,针对急性反复性癫痫发作的创新药

地西泮鼻喷雾剂由康哲药业参股的美国Neurelis公司研发,且康哲药业拥有该产品在中国大陆、香港、澳门、和台湾的全部资产。2020年1月,地西泮鼻喷雾剂获FDA批准以VALTOCO®商品名称在美国上市,用于治疗6岁及以上癫痫患者的间歇性、刻板性癫痫频繁发作活动(即癫痫丛集性发作、急性反复性癫痫发作)。该产品配方结合了基于维生素E溶剂和Intravail®吸收增强剂的独特组合,以期在鼻腔配方中获得突出的吸收性、耐受性和可靠性;与静脉注射地西泮相比,其绝对生物利用度高达96%,且变异性低。

中国活动性癫痫患者约600万,每年新发患者约40万。得到正规治疗的癫痫患者(约200万)中,仍有20%-30%无法得到有效控制,癫痫反复发作次数频繁,平均每年近70次之多。地西泮鼻喷雾剂一旦在中国获批,将成为急性反复发作癫痫患者的长期必备、安全有效的药物,市场前景可期。

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