Scilex Holding Company (SCLX) announced the presentation of data on GLOPERBA® (colchicine oral solution) at the 2024 American College of Rheumatology (ACR) Convergence conference in Washington, D.C. The data focuses on pharmacokinetic model-derived dosing for patients with moderate and severe chronic kidney disease, showcasing GLOPERBA®'s precision dosing capabilities.
Precision Dosing for Renal Impairment
GLOPERBA® stands out as the first and only liquid colchicine formulation that allows for precision dosing, including reduced daily doses (0.3 mg/day) for patients with severe renal impairment. This capability addresses a critical unmet need in managing gout flares in patients with compromised kidney function, who often require careful dose adjustments to minimize adverse effects.
The updated FDA label for GLOPERBA® reflects these dosing adjustments, providing healthcare providers with clear guidance on how to manage gout prophylaxis in patients with varying degrees of renal impairment. This is particularly important given the prevalence of chronic kidney disease and the need for effective gout management strategies in this population.
Pharmacokinetic Modeling
The data presented at the ACR Convergence conference summarizes pharmacokinetic model-derived dosing for at-risk moderate and severe chronic kidney disease patients. This modeling approach allows for more precise dose adjustments compared to traditional tablet or capsule formulations of colchicine, which do not offer the same level of flexibility.
"The presentation highlights the importance of precision dosing in patients with renal impairment," said Jaymin Shah, PhD, FCP, one of the authors of the presentation. "GLOPERBA's unique liquid formulation allows for tailored dosing regimens that can help to minimize the risk of adverse events in this vulnerable population."
Clinical Implications
Gout is a common inflammatory arthritis that affects millions of people worldwide. Patients with chronic kidney disease are at increased risk of developing gout and experiencing frequent flares. Colchicine is a commonly used medication for gout prophylaxis, but its use in patients with renal impairment requires careful monitoring and dose adjustments.
GLOPERBA® offers a significant advantage over other colchicine formulations by providing a liquid formulation that allows for precise dose adjustments. This can help to improve patient outcomes and reduce the risk of adverse events in patients with renal impairment.
