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Scilex Holding Company Announces Seeking Approval from the FDA for Modification of the Gloperba® Label to Provide Specific Dosing Guidance for Patients with Renal Impairment and Other Circumstances Where Dose Adjustment is Needed
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
About this update from Scilex Holding Company
[{"type":"text","content":"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. Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. According to data gathered by Evaluate Pharma, the gout treatment market is projected to reach $2.0 billion in the United States by 2028 with a well-defined area of unmet need.2Over 70% of gout patients have comorbid conditions that may require dose adjustments and such patients could be potential target population for Gloperba®3Over 17% of gout patients on colchicine have experienced severe gastrointestinal side effects like diarrhea. These patients may benefit from flexible dosing offered by Gloperba®4 PALO ALTO, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- 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. A recent market research study among rheumatologists revealed a high degree of interest in Gloperba® as a liquid colc...