Scilex Holding Company has announced the publication of dosing adjustment guidelines for GLOPERBA (colchicine oral solution) in a peer-reviewed journal, providing clinicians with evidence-based recommendations for treating gout patients with kidney impairment. The publication addresses a significant clinical challenge, as over 70% of gout patients have comorbid conditions that may require dose adjustments.
Addressing Critical Dosing Challenges
GLOPERBA represents the first and only liquid oral version of colchicine indicated for the prophylaxis of painful gout flares in adults. The liquid formulation allows for precision dosing and reduction of daily dose in patients with severe renal impairment, addressing a longstanding clinical need.
Patients receiving standard prophylaxis doses of colchicine for gout flares face increased risk for developing toxicity when pre-existing renal impairment or drug-drug interactions are present. Current guidelines recommend exercising caution while deferring dose adjustment to the clinician's discretion, creating uncertainty in clinical practice.
Pharmacokinetic Analysis Reveals Dosing Solutions
Analysis of pharmacokinetic model data demonstrated that most patients with renal impairment taking colchicine solid dosage formulations will experience drug levels below or above therapeutic ranges, exposing them to potential side effects. The research shows that more precise dosing with colchicine oral solution achieves optimal levels within the therapeutic window while providing greater safety.
The study established specific dosing recommendations: 0.48 mg (4 mL) for moderate renal impairment and 0.3 mg (2.5 mL) for severe renal impairment. These precise liquid doses are associated with optimal therapeutic levels and improved safety profiles compared to standard tablet formulations.
Clinical Expert Endorsement
Dr. Michael H. Pillinger, Professor of Medicine and Biochemistry and Molecular Pharmacology and Director of Rheumatology Training at NYU Clinical and Translational Science Institute, emphasized the publication's clinical significance: "This important publication will provide much needed data to guide clinical dosing of colchicine in patients with gout and chronic renal failure."
Market Position and Manufacturing
GLOPERBA is currently manufactured in the United States and represents a key commercial product for Scilex Holding Company. The company focuses on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, as well as neurodegenerative and cardiometabolic diseases.
The publication provides clinicians with evidence-based tools to optimize colchicine therapy in a vulnerable patient population, potentially improving outcomes while reducing adverse events in gout patients with compromised kidney function.
