URL Pharma, Inc., 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).
"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, M.D., R.Ph., Vice President, Branded Products and Medical Affairs, 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."
The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea. In the presence of mild-to-moderate renal or hepatic impairment, adjustment of dosing is not required for use in gout flare prophylaxis, but patients should be monitored closely for adverse effects of colchicine. 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. Full prescribing information can be found at www.colcrys.com.