URL Pharma, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Colcrys(TM) (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on July 30, 2009 for the treatment of acute gout flares when taken at the first sign of a flare.
Colcrys is an oral, branded form of colchicine that has been formulated for optimal efficacy and tolerability. It is the only single-ingredient colchicine to be approved by the FDA for the prophylaxis and treatment of gout flares. Colcrys provides a formulation with the efficacy of colchicine while avoiding most of the toxicity of the unapproved products historically on the market. Colcrys is also indicated for the treatment of Familial Mediterranean Fever (FMF) in adults and children 4 years of age or older. Colcrys is available via prescription at pharmacies nationwide.
"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).