Zurampic to treat high blood uric acid levels associated with gout: FDA approves
U.S. Food and Drug Administration has approved Zurampic (lesinurad) on December 23, 2015 to treat high blood uric acid levels related with the onset of gout. It is used with xanthine oxidase inhibitor (XOI), a drug already approved to minimize the uric acid production.
Gout is developed when a high amount of uric acid accumulates in the body and is associated with pain, redness, soreness and swelling in big toe. The production of uric acid takes place in the body when breakdown of purines occur. Generally, uric acid get dissolves in blood, and flow through kidneys and excel out from body in the form of urine. Unfortunately, sometimes uric acid accumulates in blood which lead to a harmful condition called as hyperuricemia. All this happens when kidneys are unable to expel exccess uric acid or when a person consumes purine rich diet. Although hyperuricemia does not lead to gout, but if uric acid forms crystals, then gout may occur.
According to Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in FDA's Center for Drug Evaluation and Research, "Controlling hyperuricemia is critical to the long-term treatment of gout". "Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes." Drug "Zurampic" aids the kidney to eliminate the uric acid by hampering various transporter proteins which are involved in building uric acid.
Three randomized, placebo-controlled clinical studies were conducted in which safety and efficacy of Zurampic were evaluated in combination with a xanthine oxidase inhibitor, which enrolled 1,537 participants for up to 12 months and experienced reduced serum uric acid levels as compared to placebo. Gastroesophageal reflux disease, headache, influenzaand increased blood creatinie are the most common adverse reactions.
Zurampic has a boxed warning that provides safety information for health professional or healthcare provider, however, renalfailure found to be more prevalent if used without an XOI and with higher doses than approved Zurampic doses. To further evaluate the renal and cardiovascular safety of Zurampic, FDA is also necessitating postmarketing surveillance studies. The manufacturer of Zurampic is AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.