URL Pharma said that these new dosing recommendations were issued as a result of several clinical studies designed and conducted by URL Pharma that uncovered the risk of serious interactions when colchicine is taken along with certain other prescription medications.
URL Pharma claimed that in addition to protease inhibitors, the company’s studies discovered potentially dangerous interactions between colchicine and certain hypertension medications and antibiotics. URL Pharma said that it has conducted 17 clinical trials as part of its submissions to the FDA in the 3 New Drug Applications (NDAs) filed for Colcrys.
URL Pharma said that Colcrys received approval from the FDA on July 30, 2009 for use in treating acute gout flares at the first sign of a flare, and for the treatment of FMF. Colcrys received FDA approval for the prophylaxis of gout flares on October 19, 2009.
Matthew Davis, chief medical officer, said: “The drug-drug interaction studies we conducted for Colcrys have yielded new and critically important guidance for physicians on the safe and appropriate use of colchicine, particularly among special populations in the treatment of gout.
“Prior to our work, scientifically rigorous guidance on dosing colchicine to avoid drug interactions was virtually non-existent. We urge all healthcare providers to consult the new labeling for protease inhibitors prior to concomitant use with Colcrys.”
Richard Roberts, president, chief executive officer and chairman of URL Pharma, said: “Our clinical program for Colcrys discovered these previously unknown drug-drug interactions. Patients and physicians should feel confident that they are prescribing and using a thoroughly tested, FDA-approved medication that meets all modern standards of safety, efficacy, purity, consistency and labeling.”