Scilex Holding Company 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. 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.

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 capsule.

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.