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将寻求MFDA批准对Gloperba进行修改以包括
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（纳斯达克股票代码：SCLX，“Scilex” 或 “公司”）））））是一家专注于收购、开发和商业化用于治疗急慢性疼痛的非阿片类疼痛管理产品的创新型创收公司，今天宣布将寻求美国食品药品管理局批准修改Gloperba标签，使其能够利用液体配方的剂量灵活性来满足未满足的医疗需求并向肾功能损害患者提供具体的剂量指导，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.
- 应考虑调整剂量为轻度或中度肾脏或肝脏受损的患者。
- 对于严重肾功能不全的患者，起始剂量应为0.3 mg/天。
- 对于接受透析的患者，总推荐剂量应为0.3 mg，每周给药两次。