FDA Approves Zurampic® (lesinurad) Tablets for Treatment of Hyperuricemia-Associated with Gout
The U.S. Food and Drug Administration (FDA) has approved Zurampic for the treatment of high uric acid levels associated with gout in patients that have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone. Zurampic should be used in combination with a xanthine oxidase inhibitor, such as allopurinol or febuxostat. Zurampic is a urate transporter inhibitor that works by inhibiting uric acid transporter 1 (URAT1) and organic anion transporter 4 (OAT4), major transporters responsible for the reabsorption of uric acid and allowing for renal excretion.
Three randomized, double-blind, placebo-controlled trials were used to evaluate the safety and efficacy of Zurampic in combination with a xanthine oxidase inhibitor for up to 12 months. Patients who received Zurampic and a xanthine oxidase inhibitor had greater reductions in serum uric acid levels than patients who received a xanthine oxidase inhibitor alone.
The most common side effects of Zurampic were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease. A black box warning exists for renal failure, and Zurampic should not be used in patients with severe renal impairment. Also, a number of major adverse cardiovascular events were reported during clinical trials; however, a causal relationship had not been established. Read more