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FDA Issues Approvable Letter for Oxypurinol
VANCOUVER, June 24 /PRNewswire-FirstCall/ -- Cardiome Pharma Corp (TSX: COM) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for oxypurinol for allopurinol-intolerant hyperuricemia (gout). The letter states that prior to final marketing approval, the FDA requires additional clinical and manufacturing data from Cardiome.
The approvable letter follows Cardiome's submission of an NDA package in December of 2003 under sub-part H of the Food and Drug Act. This use of oxypurinol has been declared an orphan indication in the U.S.
"While we are pleased that the FDA agrees that oxypurinol is approvable, we are disappointed with their apparent decision which will at least delay patients gaining commercial access to oxypurinol" said Bob Rieder, President & CEO of Cardiome. "The gout market opportunity is very small and Cardiome is strongly focused on its attractive cardiovascular drug development programs. We will reflect on the FDA comments and meet with the FDA prior to making any final decisions on the future of this NDA or the compassionate-use program."
Cardiome today also confirmed previous guidance regarding potential listing on NASDAQ, initiating Phase 1 studies for oral RSD1235, reporting Phase 3 results from ACT 1 for intravenous RSD1235, and completing enrollment in the Phase 2 OPT-CHF study in the remaining months of 2004.
Gout is a chronic and potentially debilitating disease characterized by painful arthritis attacks that afflicts more than two million patients in the U.S. Allopurinol is an effective treatment for hyperuricemia, accounting for approximately 70% of all gout prescriptions. While allopurinol is well tolerated by most patients, 2-4% of patients develop allergic reactions that require immediate discontinuation of the drug. Some of those patients (estimated at between 2,000 and 10,000 patients) have severe gout-related hyperuricemia and no disease-modifying treatment alternatives. These patients currently suffer painful arthritis attacks, uric acid crystal deposits in joints and skin, and in some cases kidney stones or even kidney failure. Oxypurinol has the potential to successfully treat approximately 70% of this allopurinol-intolerant patient population.
Source: Cardiome Pharma Corp.