Scilex Holding To Seek Approval Fro MFDA For Modification Of Gloperba To Include
Scilex Holding To Seek Approval Fro MFDA For Modification Of Gloperba To Include
Scilex Holding將尋求MFDA批准對Gloperba進行修改以包括
Scilex Holding Company (NASDAQ:SCLX, "Scilex" or "Company"))))), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced it will seek approval from the FDA for the modification of the Gloperba label to include its ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as set out below:
Scilex Holding Company（納斯達克股票代碼：SCLX，“Scilex” 或 “公司”）））））是一家專注於收購、開發和商業化用於治療急慢性疼痛的非阿片類疼痛管理產品的創新型創收公司，今天宣佈將尋求美國食品藥品管理局批准修改Gloperba標籤，使其能夠利用液體配方的劑量靈活性來滿足未滿足的醫療需求並向腎功能損害患者提供具體的劑量指導，如下所示：
- Patients with mild or moderate renal or hepatic impairment should be considered for dose adjustment.
- For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
- For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.
- 應考慮調整劑量爲輕度或中度腎臟或肝臟受損的患者。
- 對於嚴重腎功能不全的患者，起始劑量應爲0.3 mg/天。
- 對於接受透析的患者，總推薦劑量應爲0.3 mg，每週給藥兩次。