Scilex Holding Company presented data at the 2024 American College of Rheumatology Convergence conference in Washington, D.C., focusing on GLOPERBA® (colchicine oral solution) for gout flare prophylaxis in patients with renal impairment. The presentation highlighted the precision dosing capabilities of GLOPERBA® and its updated label reflecting dosing adjustments for various clinical situations.
Precision Dosing with GLOPERBA®
GLOPERBA® is the first and only liquid formulation of colchicine, enabling precise dosing for at-risk gout patients. This is particularly beneficial for patients with moderate to severe chronic kidney disease, who often require lower and more precise dosing than available with traditional colchicine tablets or capsules.
Updated Label and Renal Impairment
Scilex recently received FDA approval for an updated GLOPERBA® label, which now includes dosing adjustments for patients with severe renal impairment. Unlike other colchicine formulations, GLOPERBA® allows for a reduction of the daily dose to 0.3 mg/day in these patients, addressing a critical unmet need in gout management.
Pharmacokinetic Modeling
The presented data summarized pharmacokinetic model-derived dosing for at-risk patients with moderate and severe chronic kidney disease. This modeling informs the use of GLOPERBA® in patients who require lower precision dosing, which is not achievable with other currently available colchicine formulations.
About GLOPERBA®
GLOPERBA® is indicated for the prophylaxis of painful gout flares in adults. Its liquid formulation allows for tailored dosing, particularly important in patients with renal impairment who are at higher risk of adverse effects from colchicine.
Scilex's Broader Pipeline
Scilex Holding Company focuses on developing and commercializing non-opioid pain management products. Their portfolio includes ZTlido® (lidocaine topical system) for postherpetic neuralgia, ELYXYB® for acute migraine treatment, and several product candidates in development, such as SP-102 (SEMDEXA™) for lumbosacral radicular pain and SP-104 for fibromyalgia.
