Scilex seeks approval from FDA for modification of Gloperba label

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 guidelines also reflect this need. Scilex expects to launch Gloperba in the first half of 2024.