Dec. 23, 2015 -- The U.S. Food and Drug Administration on Tuesday approved the use of Zurampic (lesinurad) to reduce high levels of uric acid -- hyperuricemia -- in the blood, a major contributor to the painful condition known as gout.
The drug is meant to be used in combination with an already approved class of gout medicines called xanthine oxidase inhibitors (XOIs).
"Controlling hyperuricemia is critical to the long-term treatment of gout," Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes."
According to the FDA, gout is a painful arthritic condition that occurs when too much uric acid builds up in the body. The disease typically first appears as painful swelling and redness of the big toes.
All tissues contain substances called purines, which then break down naturally to create uric acid. Most blood-borne uric acid will pass harmlessly through the kidneys, the FDA said, but an overabundance of the acid can trigger the formation of uric crystals, which then go on to cause gout.
Zurampic, made by Wilmington, De.-based AstraZeneca, helps the kidneys excrete uric acid by blocking the function of proteins that allow the acid to be re-absorbed by the kidneys, the FDA explained.
Three randomized, placebo-controlled studies involving a total of more than 1,500 patients found that Zurampic was effective when used along with an XOI. Patients were tracked for a year and were found to have lower levels of uric acid in the blood when they received this drug combination, the FDA said.
There were side effects in some patients, including headache, flu, gastroesophageal reflux disease (chronic heartburn), and higher levels of a substance called creatinine in the blood. Zurampic will come with a boxed warning that cautions of the heightened risk for acute kidney failure, especially when the drug is used at higher doses or without an XOI.