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Two Meds Do The Trick

In early December of 2009, Ardea Biosciences, Inc. reported that the results were in on a one week trial that combined their product, RDEA594, with febuxostat. Ardea found that using the two medications together gave them a 20% improvement in the treatment of hyperuricemia and gout as compared to dosing with just one therapeutic agent. The company believes that these results suggest that the combination can resolve tophaceous gout every bit as well as current intravenous therapy.

Combination Treatment

The participants were given one of the agents for one week, and then given the medications in tandem. The researchers found there was a mean reduction of 40% for serum urate from baseline levels. After a week of the combination treatment, there was a 60% reduction from baseline levels, said Ardea.

The painful type of arthritis known as gout results from a build-up of uric acid in the blood. Ardea's product, RDEA594 acts as a selective inhibitor for URAT1 which works within the kidney to regulate the secretion of uric acid from the body. Febuxostat, known in the trade as Uloric, is used to treat gout and hyperuricemia.

A member of Ardea's scientific advisory board, John Sundy MD, PhD said, "The substantial reduction in serum uric acid observed when RDEA594 and febuxostat are co-administered indicate that these two oral agents with complementary mechanisms may be able to accelerate improvement in tophaceous gout compared to single agent therapy. I look forward to studying this combination in patients with advanced disease." Sundy is affiliated with Duke University Medical Center as an associate professor of medicine.

Dramatic Reduction

Ardea's CEO, Barry Quart said, "Similar reductions in serum urate produced when RDEA594 and febuxostat were administered alone, and the substantial reduction produced when these agents were administered in combination supports our strategy to develop RDEA594 as both monotherapy and in combination with xanthine oxidase inhibitors, such as febuxostat or allopurinol. With the dramatic reduction in serum uric acid observed when RDEA594 and febuxostat are administered in combination, together these agents may be able to produce reductions in tophaceous gout previously achieved only with intravenous therapy."

The research performed by Ardea scientists was a randomized study with placebo controls. The participants in this trial were healthy with baseline serum urate levels of over 5 mg/dL. The purpose of the trial was to assess the combination of the two agents for possible pharmacokinetic drug interactions but also to see if escalating doses of RDEA594 were safe and well-tolerated and whether they might lower serum urate when given once a day in combination with a 40 mg. dose of febuxostat.