Wednesday, October 21, 2009

Colcrys approved by FDA for prevention of gout flares...


Colchicine is a toxic natural product and secondary metabolite, originally extracted from plants of the genus  Colchicum (Autumn crocus, Colchicum autumnale, also known as "Meadow saffron"). It was used originally to treat rheumatic complaints, especially gout.

Recently (July 30, 2009 ), US FDA has approved Colcrys(TM) (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on for the treatment of acute gout flares when taken at the first sign of a flare. 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.

As per the claim by the company (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).

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, where as Colchicine has been proven to be effective in preventing flares when given in conjunction with uric acid-lowering therapy, except for the mild diarrhea. Hope patients suffering from gout will breathe a sigh of relief..

Ref : http://www.drugs.com/colcrys.html

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