新型口服液episil在国内获批,用于治疗放化疗引起的口腔黏膜炎

2019-02-24 不详 MedSci原创

日本Solasia Pharma KK公司宣布其episil口服液已获得国家食品药品监督管理局(NMPA)的批准,用于缓解化疗/或放疗引起的口腔粘膜炎(OM)。作为缓解口腔粘膜炎的唯一即用型医疗设备,episil将为国内口腔粘膜炎患者提供新的治疗选择,特别是对于接受放疗/或化疗后的癌症患者。

日本Solasia Pharma KK公司宣布其episil口服液已获得国家食品药品监督管理局(NMPA)的批准,用于缓解化疗或放疗引起的口腔粘膜炎(OM)。

OM是一种常见的副作用,化疗后的发生率达20%-40%,大约80%的大剂量化疗(如造血干细胞移植预处理)和大多数接受放疗的头颈癌患者均会产生。OM通常表现为发红、糜烂、溃疡和疼痛,影响吞咽和进食,并且经常导致抗肿瘤疗法的剂量减少、中断或延迟放疗,甚至住院治疗。目前,国内还没有该疾病的治疗方法。

episil使用瑞典Camurus AB的专利技术,是一种基于脂质的不含防腐剂的液体,粘附在口腔粘膜上,并在与口腔粘膜接触后5分钟内形成一层保护膜,从而为口腔敏感和溃疡上皮提供物理保护,缓解疼痛长达8小时。

临床结果显示,单次使用episil可在6小时内显着降低口腔粘膜疼痛评分,局部镇痛和时间持续效果均优于对照组。此外,episil易粘附于粘膜,成膜时间快(5分钟内)。患者报告味道舒适,无刺激。该试验证实了episil在OM治疗中的有效性和安全性。

Solasia公司总裁兼首席执行官Yoshihiro Arai表示:"Solasia公司的使命是"更好的药物,更美好的明天"。我们一直专注于患者,将继续努力开发治疗癌症和支持癌症治疗的创新产品。"

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    2019-10-14 songbq
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