In August 2024, the U.S. Food & Drug Administration (FDA) approved a supplemental new drug application for Gloperba—0.6 mg of colchicine in an oral solution—as a prophylactic treatment to prevent gout flares in adults. This approval includes specific information and dosage modifications relating to special patient populations and drug interactions.1
Background
In 1961, the FDA approved colchicine tablets for the treatment of adults with pain associated with gout. Its 0.6 mg/5 mL oral solution received subsequent FDA approval on Jan. 30, 2019.2-4
Gout is the most common form of inflammatory arthritis in the U.S., affecting nearly 8.3 million individuals, and may be more prevalent in men than women.5 The condition is due to monosodium urate crystals deposition in body tissues of individuals with hyperuricemia. The risk of gout increases with advancing age, which correlates with increased uric acid levels. Gout has a 30-fold higher frequency in patients who are at least 80 years old compared with those who are 20–29 years old. The risk of gout also increases in patients with metabolic syndrome and those with obesity.
Colchicine’s effectiveness as a prophylactic treatment for gout may be due to its ability to block neutrophil-mediated inflammatory responses caused by urate crystals in synovial fluid. Colchicine disrupts the polymerization of β-tubulin into microtubules, preventing the activation, degranulation and migration of neutrophils to inflammation sites. The agent also impedes the inflammasome complex found in neutrophils and monocytes that mediate activation of interleukin (IL) 1β.3
Colchicine Dosage & Use
Unlike other colchicine formulations, a patient’s dose of Gloperba can be reduced to 0.3 mg/day. More than 70% of patients with gout have comorbid conditions, such as chronic renal failure with severe renal impairment, that may require dose adjustments.6
Additionally, more than 17% of gout patients on colchicine tablets or capsules experience severe gastrointestinal sensitivity with such side effects as diarrhea. These patients may benefit from a lower dose with colchicine in an oral solution rather than the standard dose of 0.6 mg of colchicine as a tablet or capsule.1
Colchicine in an oral solution is indicated for prophylaxis of gout flares in adults and can be given without regard to meals. It is available as a concentration of 0.12 mg/mL (0.6 mg/5 mL) for adults and children 16 years and older for once or twice daily use. Its maximum recommended daily dose is 1.2 mg.
The colchicine tablet/capsule to oral solution dose conversion is:
