The Food and Drug Administration announced Aug. 21 the approval of Duzallo, a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone.
Duzallo is a fixed-dose combination of lesinurad 200 mg and allopurinol 300 mg that will be marketed by Ironwood Pharmaceuticals. It will also be available in a lesinurad 200 mg plus allopurinol 200 mg dosage.
In two phase 3 clinical trials, CLEAR 1 (n = 402) and CLEAR 2 (n = 410), researchers examined adult patients with gout who failed to achieve target sUA levels on allopurinol alone. Lesinurad in combination with allopurinol nearly doubled the number of patients who achieved the sUA target of less than 6 mg/dL at month 6, reduced the mean sUA level to less than 6 mg/dL by month 1, and maintained that level through month 12. The most common adverse reactions reported were headache, influenza, higher levels of blood creatinine, and heartburn (acid reflux).
“With Duzallo, nearly twice as many patients with uncontrolled gout may be able to achieve target serum uric acid levels compared to those patients taking allopurinol alone, which is important, considering the significant unmet need among uncontrolled gout patients to get to goal of under 6 mg/dL,” said Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood in an announcement from the company.
Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for gout, lesinurad (Zurampic). Allopurinol is an xanthine oxidase inhibitor whose action differs from that of uricosuric agents such as lesinurad. Allopurinol reduces the production of uric acid, whereas lesinurad increases renal excretion of uric acid by selectively inhibiting the action of URAT1, the uric acid transporter responsible for the majority of renal uric acid reabsorption.
Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. It has a boxed warning regarding the risk of acute renal failure.
Duzallo is expected to be commercially available early in the fourth quarter of 2017.