FDA Clears First Fixed-Dose Combination Treatment for Gout

Megan Brooks

August 21, 2017

The US Food and Drug Administration (FDA) has approved Duzallo (Ironwood Pharmaceuticals), a fixed-dose oral combination of lesinurad (Zurampic, AstraZeneca) and allopurinol (multiple brands), for the treatment of hyperuricemia associated with gout in patients for whom target serum uric acid (sUA) levels have not been achieved with allopurinol alone.

Once-daily Duzallo contains lesinurad 200 mg plus allopurinol 300 mg. Duzallo will also be available in a dose of lesinurad 200 mg plus allopurinol 200 mg. Duzallo is not recommended for the treatment of asymptomatic hyperuricemia.

Duzallo is the first drug that combines the current standard of care for gout-associated hyperuricemia, allopurinol, with the most recent FDA-approved treatment for this condition, lesinurad, the company said in a news release announcing the approval.

Allopurinol reduces the production of UA, and lesinurad increases renal excretion of UA. The FDA approved lesinurad in 2015.

"The approval of Duzallo provides a new fixed-dose and dual-mechanism treatment option to help patients with uncontrolled gout achieve target serum uric acid levels. This represents an important and needed new option in the treatment of hyperuricemia," Michael A. Becker, MD, professor emeritus of medicine, Department of Medicine, the University of Chicago, Illinois, said in the release.

"Gout is a serious and potentially progressive and debilitating inflammatory disease. 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," added Dr Becker.

In clinical trials of adults with gout for whom target sUA levels could not achieved with allopurinol alone, lesinurad in combination with allopurinol nearly doubled the number of patients in whom the sUA target of <6 mg/dL at 6 months was achieved. It reduced the mean sUA level to <6 mg/dL by 1 month and maintained that level through 12 months, the company said.

The most common adverse reactions in clinical trials were headache, influenza, increased levels of blood creatinine, and acid reflux. Duzallo has a boxed warning regarding the risk for acute renal failure. The drug should be taken in the morning with food and water, and patients should be advised to stay well hydrated and to drink about 2 L of liquid a day when taking the drug, the company said.

The company expects Duzallo to be commercially available early in the fourth quarter of 2017.

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