FDA releases Cardiome Oxyprim gout data

Cardiome's Oxyprim oxypurinol was "associated with a modest reduction in serum uric acid levels" in gout patients, according to FDA's analysis of the company's NDA. "Oxyprim appears to provide a subtherapeutic lowering of SUA for the majority of symptomatic hyperuricemic patients," FDA said. The agency's analysis was released in advance of Wednesday's Arthritis Advisory Committee meeting on the design of trials for therapies for hyperuricemia associated with chronic gout. FDA will not ask the committee to vote on any questions associated with the NDA, according to Cardiome (TSE:COM; COMRF).

COM is seeking approval of Oxyprim for gout patients who are allergic to allopurinol, which the company said is about 2% of grout patients. Up to 40% of allopurinol-intolerant patients also have allergic reactions to Oxyprim, which is a metabolite of allopurinol, according to FDA. COM estimates the total U.S. chronic gout market for Oxyprim at 7,000-14,000 patients. ...