PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a firm specializing in non-opioid pain management solutions, announced today its intention to request FDA approval for label modifications of Gloperba®, its liquid colchicine product for gout prevention. The proposed label changes aim to provide precise dosing guidance for patients with renal impairment and enhance dosing flexibility.
Gloperba® is currently the sole liquid oral colchicine medication approved for adult gout flare prophylaxis. The label update would include dosing adjustments for patients with mild or moderate renal or hepatic impairment, a 0.3 mg/day starting dose for those with severe renal impairment, and a 0.3 mg dose given twice weekly for patients on dialysis.
This move is in response to the growing need for tailored gout treatments, as over 70% of gout sufferers also contend with comorbid conditions, including kidney and liver issues, that necessitate dosage modifications. Furthermore, more than 17% of patients using colchicine have reported severe gastrointestinal side effects, which could be alleviated by the flexible dosing that Gloperba® offers.
The gout treatment market in the United States is expected to grow to $2 billion by 2028, and Scilex's initiative could address a significant portion of this market, particularly given the high interest from rheumatologists in a liquid formulation that allows for precision dosing.
Scilex anticipates launching Gloperba® in the first half of 2024. The company's strategy aligns with the American College of Rheumatology guidelines, which underscore the necessity for dose adjustment based on patient-specific factors to prevent colchicine toxicity.
The information is based on a press release statement from Scilex Holding Company.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.