Scilex Announces FDA Approval Of SNDA For Label Updates To Gloperba

(RTTNews) - Scilex Holding Company (SCLX), Thursday announced FDA approval of a Supplemental New Drug Application for Label Updates to Gloperba.

Gloperba is the only FDA-approved liquid formulation of colchicine for the prophylaxis of acute gout flares. Over 70% of gout patients have chronic kidney disease and many suffer from gastrointestinal sensitivity, necessitating a lower dose of colchicine than the standard 0.6 mg tablet or capsule.

Gloperba is expected to be the first liquid colchicine formulation that allows healthcare providers to prescribe precision dosing in at-risk patient populations, and thereby help mitigate against severe toxicity in patients.

A recent market research study among rheumatologists conducted by Scilex revealed a high degree of interest in Gloperba as a liquid colchicine formulation designed for precision dosing.