FDA Approves Duzallo, Lesinurad Plus Allopurinol Combo Drug, for Gout
The dual-action drug can reduce the production of uric acid while increasing renal excretion of uric acid.
The Food and Drug Administration (FDA) has approved Duzallo (Ironwood) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. Duzallo is not recommended for the treatment of asymptomatic hyperuricemia.
This fixed-dose combination product combines lesinurad, a uric acid transporter 1 (URAT1) inhibitor, with allopurinol, a xanthine oxidase inhibitor in one tablet. Allopurinol reduces the production of uric acid while lesinurad increases renal excretion of uric acid by selectively inhibiting the action of URAT1, the UA transporter responsible for the majority of renal UA reabsorption.
The approval of Duzallo was based on the clinical program supporting the Zurampic (lesinurad; Ironwood) new drug application and a pharmacokinetic study that evaluated the bioequivalence of the fixed-dose combination compared to co-administration of the separate active ingredients; there have been no Phase 3 clinical trials with Duzallo.
In clinical trials (CLEAR 1 and CLEAR 2) for adult patients with gout who failed to achieve target serum uric acid (sUA) levels on allopurinol alone, lesinurad in combination with allopurinol nearly doubled the number of patients who achieved sUA target of <6mg/dL at month 6 (Study 1: 54% lesinurad + allopurinol vs. 28% placebo + allopurinol; Study 2: 55% lesinurad + allopurinol vs. 23% placebo + allopurinol), reduced the average sUA level to <6mg/dL by month 1 and maintained that level throughout the 12-month studies.
Duzallo tablets will be supplied as 200mg/200mg and 200mg/300mg strengths in 5-, 30-, and 90-count bottles. Ironwood expects to make the product available early in the fourth quarter of 2017.
- Now Approved: The first and only therapy that addresses both mechanisms of hyperuricemia in gout with one pill [press release]. Ironwood Pharmaceuticals, Inc. Accessed on August 24, 2017.