Colcrys, a new colchicine formulation, has received marketing clearance for the prevention of gout flares. The FDA first approved the oral medication in July for the treatment of acute gout flares when taken at the first sign of a flare. Colcrys is the only single-ingredient colchicine to be approved for the prophylaxis and treatment of gout flares, said the drug’s maker, URL Pharma Inc.

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.

“Uric acid-lowering agents are highly effective and well-established in chronic gout management, but the initiation of this therapy may sometimes trigger a gout flare,” said Matthew R. Davis, MD, RPh, Vice President for Branded Products and Medical Affairs at URL Pharma. “Colchicine has been proven to be effective in preventing flares when given in conjunction with uric acid-lowering therapy, and with Colcrys, doctors can now prescribe colchicine with greater confidence.”