FDA Approval: New Gout Medication for High Uric Acid Levels

DECEMBER 22, 2015
Caitlyn Fitzpatrick
The latest US Food and Drug Administration (FDA) approval goes to a Zurampic (lesinurad), a drug to help treat gout, a type of arthritis classified by severely painful joints.

Gout occurs when there is too much uric acid builds up in the body. When this happens, patients experience redness and soreness. Zurampic was approved to treat high levels of uric acid in blood, called hyperuricemia, when used with a xanthine oxidase inhibitor (XOI), which is a drug used to reduce uric acid production in the body.

“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 news release. Zurampic helps the kidneys excrete uric acid by inhibiting the transporter proteins involved in uric acid reabsorption, according to the statement. Three studies consisting of 1,537 patients for up to one year supported the safety and efficacy of the drug. The Zurampic-XOI combination reduced serum uric acid levels in comparison to placebos.

Headache, influenza, increased blood creatinine, and gastroesophageal reflux disease were the most common side effects associated with Zurampic. However, the FDA is requiring a study to further analyze safety for renal and cardiovascular health.

“Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes,” Chowdhury said.

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