Scilex Holding Gets FDA Approval for Precision Dosing on GLOPERBA® Label

Scilex Holding Company has announced the final approval from the FDA for Precision Dosing updates to the GLOPERBA® label. GLOPERBA® is significant as it is the first and only liquid oral colchicine formulation for preventing painful gout flares in adults. Gout, an extremely painful arthritic condition, affects approximately 9.2 million individuals in the United States. With an increasing number of gout cases each year, the demand for effective treatments continues to grow. Data from Evaluate Pharma suggests that the gout treatment market in the U.S. will reach $2.0 billion by 2028, highlighting a clear need for improved therapeutic options.

A large proportion of gout patients, over 70%, have additional health conditions that necessitate dosage adjustments of their medications. These patients represent a key demographic for GLOPERBA®. Additionally, more than 17% of patients on standard colchicine experience severe gastrointestinal side effects, such as diarrhea. These patients could benefit from the flexible dosing provided by GLOPERBA®. Unlike other colchicine options, GLOPERBA® can accommodate a reduced daily dosage in patients with severe renal impairment, offering a dose as low as 0.3 mg per day.

Scilex Holding Company, based in Palo Alto, California, focuses on developing and commercializing non-opioid pain management products. The company announced the FDA’s approval of a Supplemental New Drug Application for label updates to GLOPERBA®. This liquid formulation of colchicine is designed to prevent acute gout flares and is especially useful for patients with chronic kidney disease or gastrointestinal sensitivities. GLOPERBA® offers healthcare providers the ability to prescribe precision dosing to mitigate the risk of severe toxicity in at-risk patients. The standard dosage for prophylaxis is typically 0.6 mg once or twice daily, but GLOPERBA® allows for safe and effective management at lower doses. For those treated with doses below 0.6 mg, a 150 ml bottle of GLOPERBA® is expected to last over 30 days, providing additional value to patients.

A recent market study among rheumatologists indicated a high level of interest in GLOPERBA® as a liquid colchicine formulation tailored for precision dosing. Clinicians treating gout in adults showed a strong preference for using GLOPERBA® over traditional tablets or capsules, particularly for patients who require lower doses to avoid colchicine toxicity. This need is also reflected in the American College of Rheumatology (ACR) guidelines.

GLOPERBA® is specifically indicated for the prophylaxis of gout flares in adults. It is noted that its safety and effectiveness for the acute treatment of gout flares during prophylaxis have not been established. Additionally, GLOPERBA® is not intended to treat pain from other causes as it is not an analgesic medication.

For dosage and administration, the recommended dosage of GLOPERBA® for adults and adolescents over 16 years old is 0.6 mg once or twice daily, with a maximum recommended dose of 1.2 mg per day. The liquid solution of colchicine in GLOPERBA® is administered orally, without regard to meals. Prophylactic therapy may be beneficial during the first six months of uric acid-lowering therapy.

Scilex Holding Company continues to innovate in the field of non-opioid pain management, aiming to improve patient outcomes with products like GLOPERBA®. The company remains dedicated to meeting the needs of patients with acute and chronic pain through advanced and effective therapies.

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