The Federal Drug Administration (FDA) has approved lesinurad (Zurampic; AstraZeneca, Wilmington, Delaware) 200 mg tablets in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout.
“Controlling hyperuricemia is critical to the long-term treatment of gout,” Badrul Chowdhury, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement. “Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes.”
The drug assists the kidney excrete uric acid by impeding the function of transporter proteins involved in uric acid reabsorption in the kidney.
The FDA evaluated the safety and efficacy of the drug in 3 randomized, placebo-controlled studies in combination with an XOI in 1537 participants for up to 12 months. The treated patients had reduced serum uric acid levels compared with the placebo.
Adverse events associated with this medication include: headache, increased blood creatinine, and gastroesophageal reflux disease. Influenza has also been reported.
An FDA advisory committee recommended the approval of lesinurad in October 2015.
FDA approves Zurampic to treat high blood uric acid levels associated with gout. Federal Drug and Administration (FDA). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm478791.htm. Accessed January 4, 2016.