Business
Scilex Holding Company Announces FDA Final Approval to Precision Dosing for GLOPERBA® Label
FDA Final Approval to Precision Dosing for GLOPERBA® Label.We believe GLOPERBA® is the first and only liquid oral version of the anti-gout medicine colchicine
About this update from Scilex Holding Company
[{"type":"text","content":"FDA Final Approval to Precision Dosing for GLOPERBA® Label.We believe 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 U.S. 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 are a potential target population for GLOPERBA®.3Over 17% of gout patients on colchicine experienced severe gastrointestinal side effects like diarrhea. These patients may benefit from flexible dosing offered by GLOPERBA®.4Unlike other colchicine formulations, GLOPERBA® allows reduction of daily dose in patients with severe renal impairment (0.3 mg/day). PALO ALTO, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “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 FDA approval of a Supplemental New Drug Application for Label Updates to GLOPERBA®. GLOPERBA® is the only FDA-approved liquid formulation of colchicine for the prophylaxis of acute gout flares. Over 70% of gout patients have chronic kidney disease and many suffer from gastrointestinal sensitivity, necessitating a lower dose of colchicine than the standard 0.6 mg tablet or capsule. GLOPERBA® is expected to be the first liquid colchicine formulation that allows healthcare providers to prescribe precision dosing in at-risk patient populations, and thereby help mitigate against severe toxicity in patients. Healthcare providers can now safely and effectively manage such patients at doses below 0.6 mg once or twice daily, which is the standard dose for prophylaxis. In patients who are treated at lower doses than 0.6 mg, the 150 ml bottle of GLOPERBA® is expected to last more than 30 days, delivering additional value to patients. Unlike other colchicine formulations, GLOPERBA® allows reduction of daily dose in patients with severe...