TAP Pharmaceutical Products Incorporation announced that it has submitted a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for Febuxostat 80 mg and 120 mg for the management of hyperuricemia in patients with chronic gout.

Hyperuricemia, elevated uric acid levels in the body, is related with gout, a painful type of arthritis. Febuxostat, an oral, once-daily medication, is a novel non-purine, selective inhibitor of xanthine oxidase studied for its effects on lowering levels of serum uric acid in patients with gout. TAP licensed Febuxostat from Teijin Pharma Ltd, based in Tokyo, Japan.

The NDA submission includes one of the largest Phase III studies of chronic gout patients in United States. This randomized, controlled, 52-week study involved 760 patients with diagnosed gout and sUA level greater than or equal to 8.0 mg/dL. Febuxostat 80 mg daily and 120 mg daily reached the study's primary endpoint of lowering sUA levels to below 6 mg/dL for three consecutive months, compared to treatment with allopurinol 300 mg daily, the most commonly used treatment in chronic gout. Experts identify that the standard goal in the treatment of chronic gout is the reduction and maintenance of sUA levels of less than 6 mg/dL.

In addition to treating acute attacks of arthritis, the management of chronic gout includes control of serum urate level. In the clinical studies, more patients taking Febuxostat than allopurinol achieved the target level of less than 6.0 mg/dL.

The overall incidence of adverse reactions in clinical studies was alike among treatment groups. The most commonly reported adverse reactions are: liver function test abnormalities, diarrhea, headache and nausea. Adverse events among trial participants were normally self-limiting and mild to moderate in severity.