FDA approves new label for Gloperba enabling precision dosing for gout prophylaxis
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Key takeaways:
- The FDA approved an updated label for Gloperba allowing for precision dosing in at-risk patient populations.
- Precision dosing can mitigate risks for severe toxicities, such as in renal impairment.
The FDA has approved an updated label for Gloperba, an oral liquid colchicine formulation, allowing for precision dosing, according to a press release from Scilex Holding Company.
Gloperba (colchicine, Scilex) is the only liquid colchicine formulation for the prevention of acute gout flares approved by the FDA, the company said. Its dosage can now be tailored for at-risk patients to mitigate the chances of severe toxicities, according to the release.
“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,” Scilex said in the release. “... Healthcare providers can now safely and effectively manage such patients at doses below 0.6 mg once or twice daily, which is the standard dose for prophylaxis.
“Unlike other colchicine formulations, Gloperba allows reduction of daily dose in patients with severe renal impairment (0.3 mg/day),” the company added.
Patients treated at doses lower than 0.6 mg can expect a 150 mL bottle of Gloperba to last longer than 30 days, according to the release.
Gloperba’s recommended dosage is 0.6 mg once or twice daily for adults and adolescents, and the maximum recommended dose is 1.2 mg per day. The drug contains 0.12 mg of colchicine per milliliter.
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