Scilex Holding Company Announces FDA Approval For Commercial Manufacturing Of Gloperba, A Prophylactic Treatment For Gout Flares In Adults, To Launch June 10, 2024

Author: Benzinga Newsdesk | June 06, 2024 02:57pm

• 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.2
• Over 70% of gout patients have comorbid conditions that may require dose adjustments and such patients could be 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
• Scilex 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.

Posted In: SCLX