Febuxostat Submitted for FDA Approval in Chronic Gout
Based on results from a phase 3 clinical trial, TAP Pharmaceutical Products Inc., the makers of febuxostat, have submitted an application seeking FDA approval for febuxostat in the management of hyperuricemia in patients with chronic gout. Results from a Phase 3 clinical trial showed that daily oral febuxostat (80 or 120 mg) is effective in reducing the level of serum uric acid in subjects with gout and hyperuricemia compared to allopurinol 300 mg per day. Safety of both doses of febuxostat was comparable to allopurinol, currently the only approved treatment for gout. (see summary from 2004 ACR Highlights)