Scilex Holding To Seek Approval Fro mFDA For Modification Of Gloperba To Include

Author: Benzinga Newsdesk | March 20, 2024 11:02am

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:

• 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.

Posted In: SCLX