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Scilex Holding Company announces the U.S. FDA has approved the sNDA for commercial manufacturing of Gloperba® which will be launched in the US in the week of June 10th 2024
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
About this update from Scilex Holding Company
[{"type":"text","content":"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. The gout treatment market is projected to be $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 could be 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®4Scilex is well-positioned to market and distribute its third commercial non-opioid product, Gloperba®: Scilex has a direct distribution network to national and regional wholesalers and pharmacies throughout the U.S.Scilex has an experienced commercial and managed care team that has successfully launched and grown market access for ZTlido® (lidocaine topical system) 1.8% to more than 225 million covered lives in the U.S. as well as successfully launching Elyxyb® (celecoxib oral solution) in the U.S. in April 2023, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. PALO ALTO, Calif., June 06, 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 that it has the FDA approval of commercial manufacturing of Gloperba®, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. and will launch in June 2024. Scilex will stock Gloperba® in all major wholesalers and pharmacies starting June 10, 2024. Gloperba® is a highly complementary commercial asset that allows the Company to provide physicians with another tool in their non-opioid pain management armamentarium to treat gout earlier in the patient journey as the Company continues to work towards re-defining the role of opioids as a last resort rescue medication. Gloperba® is a novel liquid colchicine formulation with a...