Scilex Holding Company Sets Launch Price Of $595 Per 150ml Bottle Of Gloperba, Its Liquid Oral Version Of The Anti-Gout Medicine Colchicine Indicated For The Prophylaxis Of Painful Gout Flares In Adults; Expected Plans To Launch In The First Half Of 2024

Author: Benzinga Newsdesk | March 05, 2024 10:04am

• 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 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 plans to launch Gloperba® in the first half of 2024 with a launch price of $595 per 150ml bottle of liquid colchicine formulation.
• Scilex believes it is well-positioned to market and distribute Gloperba® in the U.S.:
  • 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) 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., March 05, 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 expected plans to launch Gloperba, its novel liquid colchicine formulation, in the first half of 2024 with a launch price of $595 per 150ml bottle. 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.

A recent market research study among rheumatologists conducted by Scilex revealed a high degree of interest in Gloperba® as a liquid colchicine formulation designed for precision dosing.5 Specifically, clinicians using colchicine for prophylaxis of gout flares in adults indicated a strong likelihood to use Gloperba® instead of tablets/capsules in certain at-risk patient populations who have a clinical need for lowered precision dosing to mitigate the risk of colchicine toxicity. Notably, the American College of Rheumatology (ACR) guidelines also reflect this need.6

For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com.

For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com.          

Posted In: SCLX