FDA Approves Drug in Use for Nearly 200 Years

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The U.S. Food and Drug Administration (FDA) recently approved a drug that has been in use for nearly 200 years. The use of colchicine for the gout dates back to 1810.

Colchicine (Colcrys) is derived from the dried seeds of a plant known as the autumn crocus or meadow saffron (Colchicum autumnale). Physicians have long used it to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder.

Treatment of acute gout has long used an hourly dosing regimen that proved effective against the inflammatory disorder but often ended in gastrointestinal toxicity (diarrhea, nausea, vomiting, abdominal pain).

As part of the FDA approval a dosing study was done to evaluate dosage safety. A multicenter, randomized, double-blind, placebo-controlled trial of patients meeting American College of Rheumatology criteria for gout who were assigned to one of three treatment groups within 12 hours of a gout flare, as follows:

  • Group 1: high-dose colchicine (1.2 mg, then 0.6 mg hourly for 6 hours [4.8 mg total])
  • Group 2: low-dose colchicine (1.2 mg, then 0.6 mg in 1 hour [1.8 mg total] followed by 5 placebo doses hourly)
  • Group 3: placebo (2 capsules, then 1 capsule hourly for 6 hours)

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The trial found that a statistically significantly greater proportion of patients in the low-dose (38%) and high-dose (33%) colchicine groups achieved a 50% reduction in pain in the target joint compared to placebo (16%). Additionally, the rate of gastrointestinal adverse events (diarrhea, nausea, vomiting, abdominal pain) was considerably lower in low-dose patients (26%) compared to high-dose patients (77%). In addition, there were no severe adverse events reported in low-dose patients compared to 10 reported in high-dose patient.

Gout is a complex disorder that can affect anyone. Men are more likely to get gout than women are, but women become more susceptible to gout after menopause. Symptoms of gout are almost always acute, occurring suddenly. Often they occur at night.

Symptoms of Gout include:

Intense joint pain. Gout usually affects the large joint of your big toe but it can occur in your feet, ankles, knees, hands and wrists. If untreated, the pain typically lasts five to 10 days and then stops. The discomfort subsides gradually over one to two weeks, leaving the joint apparently normal and pain-free.

Other symptoms of gout also include Inflammation and redness. The affected joint or joints become swollen, tender and red.

Source
FDA News Release
Mayo Clinic

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