Cardiome Pharma Corp announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking marketing approval for oxypurinol (proposed tradename: Oxyprim), for the treatment of allopurinol-intolerant hyperuricemia (gout). The NDA application was submitted under the provisions of the Orphan Drug Act and under Subpart H of the Food and Drug Act in the US.
"This application represents a significant milestone for Cardiome in several ways" stated Cardiome CEO Bob Rieder. "Most importantly, it may begin transition of Cardiome from development-stage to commercial-stage."
The treatment of allopurinol-intolerant hyperuremic gout patients with oxypurinol has been designated an orphan drug programme by the FDA. Orphan drug status is typically granted to drug development programmes for "rare diseases" (high-need patient population in the US of up to 200,000 patients). Orphan drug designation provides at least seven years of mandated market exclusivity in the US market. In addition, such orphan drug programmes often qualify for expedited review by the FDA and are exempt from the FDA user fees ordinarily charged to submit an NDA.
NDA application starts an initial review period of the application by the FDA to ensure the sufficiency of the NDA package. About 30 per cent of NDA applications fail such review, and are returned to the sponsor for further work. The remaining NDA applications are then given full review.
Cardiome is currently in discussions with various companies regarding arrangements to distribute Oxyprim, if approved. No final decision has yet been made as to whether Cardiome will sell Oxyprim directly or enter into other marketing arrangements.
Gout is a chronic and potentially debilitating disease characterized by painful arthritis attacks that afflicts more than two million patients in the US. Allopurinol is an effective treatment for hyperuricemia, accounting for approximately 70 per cent of all gout prescriptions. While allopurinol is well tolerated by most patients, 2-4 per cent 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. Oxyprim has the potential to successfully treat approximately 70 per cent of this allopurinol-intolerant patient population.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company. Cardiome has three late stage clinical drug programmes focused on atrial arrhythmias, congestive heart failure, and hyperuricemia (gout).