FDA Approves Duzallo for Hyperuricemia Associated With Uncontrolled Gout

gout tophi
gout tophi
The US FDA has approved a new fixed-dose and dual-mechanism treatment option for uncontrolled gout.

Duzallo™, a fixed-dose combination of lesinurad and allopurinol, was approved by the US Food and Drug Administration (FDA) to treat hyperuricemia associated with gout in patients who have not reached target serum uric acid (sUA) levels using allopurinol alone.

Duzallo is a once daily tablet that provides the benefits of both lesinurad, a recently approved urate transporter inhibitor, and allopurinol, the current standard treatment for hyperuricemia. The combination ensures that both underlying causes of hyperuricemia ­– overproduction and underexcretion of uric acid – are treated. 

Duzallo, scheduled for commercial availability in the fourth quarter of 2017, is the first drug to combine both agents.

“I’d recommend Duzallo for patients who have not responded to a prior trial of allopurinol at the highest dose deemed safe and effective in the past,” Michael A Becker, MD, professor emeritus of medicine, Department of Medicine, The University of Chicago, told Rheumatology Advisor.

The efficacy and safety of the allopurinol and lesinurad combination were established in two clinical trials, CLEAR 1 (ClinicalTrials.gov Identifier: NCT01510158) and CLEAR 2 (NCT01493531) in which the number of patients who were able to achieve sUA target levels nearly doubled.

Duzallo should not be prescribed to patients with estimated creatinine clearance of <30 mL/min, end-stage renal disease, and patients on dialysis. Duzallo is also contraindicated in patients with tumor lysis syndrome, Lesch-Nyhan syndrome, or prior known hypersensitivity to allopurinol.

Duzallo comes with the following prescribing precautions: adverse reactions related to renal function, skin rash and hypersensitivity, hepatotoxicity, major adverse cardiovascular events (including cardiovascular deaths, nonfatal myocardial infarctions, and nonfatal strokes), bone marrow depression, increase in prothrombin time, and drowsiness.

The most common adverse reactions identified were skin rash, nausea, and diarrhea.

Duzallo is not recommended for the treatment of asymptomatic hyperuricemia.


CLEAR 1 and CLEAR 2 were funded by Duzallo manufacturer Ironwood Pharmaceuticals.

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Ironwood Pharmaceuticals announces FDA approval of DUZALLO (lesinurad and allopurinol) for the treatment of hyperuricemia in patients with uncontrolled gout [news release]. Published August 21, 2017. Accessed August 21, 2017.