Duzallo, which is a fixed-dose combination of lesinurad and allopurinol, is intended to treat hyperuricemia in patients with uncontrolled gout.
The drug is likely to be commercially launched in the latter part of the year should it be approved by the FDA.
Lesinurad is currently approved under the brand name Zurampic by the FDA and needs to be administered in combination with a a xanthine oxidase inhibitor (XOI) like allopurinol or febuxostat for treating hyperuricemia in gout patients who do not achieve the target serum uric acid (sUA) level when treated with a XOI alone.
A once-daily oral tablet, lesinurad decreases reabsorption of uric acid and in turn promotes renal excretion of uric acid. Its dual-mechanism along with an XOI can handle inefficient excretion and also overproduction of uric acid, said the US based pharma.
Once approved, Ironwood stated that Duzallo will be in a position to become the first treatment to provide the dual-mechanism of action in a single pill to be taken daily once.
As per Ironwood, Duzallo has secured the NDA review based on the clinical trial supporting the NDA for Zurampic as well as a pharmacokinetic trial that studied the bioequivalence combination of lesinurad and allopurinol in a fixed dose in comparison to lesinurad and allopurinol tablets administered separately.
Through the demonstration in two pivotal Phase III clinical trials dubbed CLEAR 1 and CLEAR 2, the efficacy and safety of lesinurad and allopurinol when co-administered separately were studied which is said to have supported the NDA for Zurampic.
Adult patients with gout failing to achieve target sUA levels when subjected to only allopurinol were evaluated in the clinical trials where the addition of Zurampic almost doubled the number of patients achieving the target of <6 mg/dL during the sixth month, besides also decreasing the mean sUA to under 6mg/dL by the first month and sustaining that level up to the twelfth month.