The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Duzallo (lesinurad/allopurinol fixed-dose combination; Ironwood) for the treatment of hyperuricemia in patients with uncontrolled gout.

The NDA submission for Duzallo was supported by data from the Zurampic (lesinurad; Ironwood) clinical trial program and a pharmacokinetic study evaluating the bioequivalence of the fixed-dose combination compared to lesinurad and allopurinol co-administered separately. Results of these trials showed that the addition of Zurampic to a xanthine oxidase inhibitor (XOI) nearly doubled the number of patients who achieved target serum uric acid (sUA) levels of <6mg/dL at month 6. In addition, the fixed-dose combination reduced the mean sUA to <6mg/dL by month 1 and maintained that level through month 12. 

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Lesinurad, a URAT1 inhibitor, was recently approved in combination with a XOI for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a XOI alone. It works by increasing the renal excretion of uric acid through the selective inhibition of URAT1, the transporter responsible for the majority of renal uric acid reabsorption. Allopurinol is a XOI which reduces the production of uric acid. Duzallo, as a combination product, exerts this dual-mechanism which can address both the inefficient excretion and the overproduction of uric acid.

The FDA is expecting the Prescription Drug User Fee Act (PDUFA) target action date to occur in the second half of 2017. If approved, Duzallo would become the first gout treatment in a daily fixed-dose combination with a dual mechanism of action.

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