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Scilex Holding Announces FDA Final Approval To Precision Dosing For GLOPERBA Label

Benzinga ·  Aug 29 21:02
  • 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.2
  • Over 70% of gout patients have comorbid conditions that may require dose adjustments, and such patients are a potential target population for GLOPERBA.3
  • Over 17% of gout patients on colchicine experienced severe gastrointestinal side effects like diarrhea. These patients may benefit from flexible dosing offered by GLOPERBA.4
  • Unlike 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.

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