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Duzallo: First combination gout drug with allopurinol & lesinurad approved by FDA




Patients with gout will soon have a new treatment option available in pharmacies following the US Food and Drug Administration's (FDA) approval of Duzallo (allopurinol, lesinurad). The once-daily oral medicine was developed by Ironwood Pharmaceuticals and is indicated for the treatment of hyperuricemia in gout patients for whom allopurinol is not effective in achieving their target serum uric acid levels. 

Gout is a condition in which sharp crystals form in and around the joints, leading to swelling, tenderness, and severe pain. The crystals form due to high levels of uric acid in the blood. Patients with conditions such as diabetes, obesity, kidney problems and high blood pressure are more prone to gout, the painful symptoms of which usually last for between three and ten days. Gout is often managed with lifestyle and dietary changes, although medication can prevent further flare ups and relieve symptoms when they occur. 

Duzallo is the first drug to combine allopurinol, the standard treatment for gout, with lesinurad, which gained FDA approval in December 2015. Lesinurad helps the kidneys excrete uric acid by inhibiting the function of transporter proteins involved gun the reabsorption of uric acid in the kidneys. Allopurinol is a xanthine oxidase inhibitor that reduces production of uric acid, helping prevent attacks of gout. 

Michael A Becker, MD, professor emeritus of medicine in the Department of Medicine at the University of Chicago, explained: "Getting patients with gout to serum urate goal, and keeping them at or below goal, are essential to success in treating these patients."

"Duzallo will help reduce the significant unmet need among patients in the US who fail to get their serum uric acid levels to goal despite taking allopurinol alone," he asserted. 

Senior vice-president of marketing and sales and chief commercial officer at Ironwood Tom McCourt claimed the availability of Duzallo could help nearly twice as many patients with uncontrolled gout achieve target serum uric acid levels compared to those only prescribed allopurinol. 

Another medication used to treat gout is Uloric (febuxostat). Earlier this year, the FDA announced it is evaluating the need for further regulatory action regarding Uloric, due to possible drug reactions with eosinophilia and systemic symptoms.