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FDA Approves Colcrys (Colchicine, USP) For Gout Flares Prevention


The US Food and Drug Administration (FDA) approved Colcrys™ (colchicine, USP) at the end of July 2009 for the treatment of acute gout flares when taken at the first sign of a flare. It has now been approved for prophylaxis (prevention) of gout flares.

Colcrys is an oral, branded form of colchicine that has been formulated for optimal efficacy and tolerability. Colcrys provides a formulation with the efficacy of colchicine while avoiding most of the toxicity of the unapproved products historically on the market.

“With the FDA’s approval of Colcrys for the prevention of gout flares, patients and physicians will now be able to realize the full therapeutic potential of Colcrys as a cornerstone therapy in the management of gout,” said Richard Roberts, M.D., Ph.D., President, CEO and Chairman, URL Pharma. “Our clinical research on colchicine – the first of its kind ever conducted -- has brought colchicine manufacturing, dosing, safety and efficacy information into compliance with current FDA standards.”

Two randomized clinical trials assessed the efficacy of colchicine 0.6 mg twice a day for the prophylaxis of gout flares in patients initiating treatment with uric-acid lowering therapy. In both trials, treatment with colchicine decreased the frequency of gout flares. Colchicine has been shown to be well-tolerated when paired with uric acid-lowering agents such as allopurinol. The dosing of Colcrys for gout flare prophylaxis is one tablet (0.6 mg) once or twice a day. The maximum daily dose for prophylaxis is two tablets (1.2 mg).

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The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea. In patients with severe renal impairment, the starting dose for prophylaxis of gout flares should be 0.3 mg per day and any increase in dose should be done with close monitoring. For patients undergoing dialysis, the total recommended dose for prophylaxis of gout flares should be 0.3 mg given twice a week with close monitoring. In patients with severe hepatic impairment, a dose reduction may be needed in prophylaxis of gout flares.

Gout is a painful form of arthritis that affects an estimated 3 to 5 million Americans, most commonly adult men. It occurs when excess uric acid in the body is deposited as needle-like crystals, or tophi, in the joints or soft tissues, which cause inflammatory arthritis and can lead to gout flares typically lasting three to 10 days.

Gout flares are characterized by intermittent swelling, redness, heat, joint stiffness and pain, which are often excruciating and can be debilitating enough to significantly interfere with work, social activities and daily living. For many people, gout initially affects the joint of the big toe, though it can also affect other joint areas such as the ankles, heels, knees, wrists, fingers and elbows.

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