恆瑞醫藥(600276.SH):SHR8554注射液能夠有效治療腹部手術後中重度疼痛
格隆匯12月6日丨恆瑞醫藥(600276.SH)公佈,近日,公司及子公司上海恆瑞醫藥有限公司、成都盛迪醫藥有限公司研發的SHR8554注射液III期臨牀試驗(SHR8554-301)主要研究終點結果達到方案預設的優效標準。研究結果表明,SHR8554注射液能夠有效治療腹部手術後中重度疼痛,顯著提高受試者對鎮痛治療的滿意度。公司將於近期向國家藥品監督管理局藥品審評中心遞交上市前的溝通交流申請。
SHR8554-301研究是一項評估SHR8554注射液用於腹部手術後鎮痛的有效性和安全性的III期臨牀研究。由華中科技大學同濟醫學院附屬協和醫院陳向東教授擔任主要研究者,全國55家中心共同參與。主要療效指標是開始輸注負荷劑量試驗用藥品後24小時內靜息狀態疼痛強度差異的時間加權和(SPID24),次要療效指標包括不同時間點的疼痛強度差異時間加權和(SPID)、疼痛緩解評分時間加權和(TOTPAR)、補救鎮痛藥物的累積使用量、補救鎮痛次數、鎮痛滿意度評分和安全性等。
本研究共入組528例受試者,手術結束後的4小時內任意時刻靜息狀態下疼痛評分≥4分的受試者按照1:1:1:1隨機進入SHR8554注射液0.75mg組、SHR8554注射液1.0mg組、嗎啡組或安慰劑組接受治療。研究結果表明,SHR8554 注射液能夠有效治療腹部手術後中重度疼痛,顯著提高受試者對鎮痛治療的滿意度。
SHR8554是一種靶向μ阿片受體(MOR)的小分子藥物,可激活MOR受體,適用於鎮痛治療。國外已有同類產品Trevena公司開發的Oliceridine(商品名:Olinvyk)於2020年在美國獲批上市銷售,暫未查詢到該產品2020年全球銷售數據。截至目前,SHR8554相關項目累計已投入研發費用約7977萬元。
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