Seek approval from the FDA for the modification of the Gloperba label to include its ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as set out below:
Patients with mild or moderate renal or hepatic impairment should be considered for dose adjustment.
For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.
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 United States 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 potential target population for Gloperba3
Over 17% of gout patients on colchicine have experienced severe gastrointestinal side effects like diarrhea. These patients may benefit from flexible dosing offered by Gloperba4
PALO ALTO, Calif., March 20, 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 it will seek approval from the FDA for the modification of the Gloperba label to include its ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as set out below:
Patients with mild or moderate renal or hepatic impairment should be considered for dose adjustment.
For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.
A recent market research study among rheumatologists 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
Scilex expects to launch Gloperba in the first half of 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. Approximately 70% of gout patients have chronic kidney disease stage 2 and many suffer from gastrointestinal sensitivity, necessitating a lower dose of colchicine than the standard 0.6 mg tablet or capsule3. Gloperba is the first and only liquid colchicine formulation that allows healthcare providers to prescribe precision dosing in these at-risk patient populations, and thereby help mitigate against severe toxicity in patients. Healthcare providers can now safely and effectively manage these patients at doses below 0.6 mg once or twice daily, which is the standard dose for prophylaxis. For patients who are treated at doses lower than 0.6 mg, the 150 ml bottle of Gloperba is expected to last longer than 30 days, delivering additional value to patients.