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海思科(002653.SZ):獲得利魯唑口溶膜上市許可申請受理通知書
格隆匯 05-10 16:37

格隆匯5月10日丨海思科(002653.SZ)公佈,公司於近日收到國家藥品監督管理局下發的《受理通知書》,為利魯唑口溶膜。

EXSERVAN是由Aquestive公司使用其PharmFilm®創新藥物遞送技術開發的利魯唑口服薄膜製劑,已於2019年11月獲得美國食品藥品監督管理局(FDA)的批准,用於治療肌萎縮側索硬化症(ALS)。

利魯唑口溶膜利用PharmFilm技術的粘膜粘附特性,可粘附於口腔內,在3-5分鐘內完全分解,易於吞嚥,避免嗆咳(通過了FDA指定的吞嚥測試),並且不受唾液分泌過多或過少的影響。利魯唑口溶膜克服了片劑的侷限性,與口服混懸液相比,簡化用藥過程,減少吞嚥困難患者的吞嚥負擔,降低嗆咳風險,吞嚥更安全,接受度更高,可進一步提高吞嚥困難患者用藥的便利性和依從性。利魯唑口溶膜適合吞嚥困難患者自主長期給藥,節約家庭護理成本和醫療成本,併為牴觸口服溶液以及拒絕經皮內鏡胃造瘻術(PEG)的吞嚥困難患者提供優先選擇,具有明顯的臨牀優勢。利魯唑口溶膜可解決並滿足絕大多數ALS患者,尤其是重度吞嚥障礙患者的臨牀需求,實現真正意義上的簡化用藥,減輕患者的吞嚥負擔,降低嗆咳風險,提高患者用藥的便利性和依從性,為臨牀提供一種治療優選。

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