FDA Approves Novel Fixed-Dose Combo Treatment for Gout

The FDA has approved a new fixed-dose combination treatment for hyperuricemia in patients with uncontrolled gout. Duzallo, manufactured by Ironwood Pharmaceuticals, is a once-daily combination of lesinurad (Zurampic, AstraZeneca) and allopurinol designed to achieve target serum uric acid (sUA) levels in patients who cannot do so with allopurinol alone.

Duzallo is the first FDA-approved fixed-dose combination oral treatment that addresses both underlying causes of hyperuricemia in gout, over-production and under-excretion of sUA, in a single tablet.

The FDA’s approval is based on a clinical program supporting the new drug application for lesinurad (Zurampic), as well as on the results of a pharmacokinetic study that evaluated the bioequivalence of the fixed-dose combination of lesinurad and allopurinol compared with co-administration of separate tablets. In phase 3 clinical trials of adult patients with gout who failed to achieve target sUA levels on allopurinol alone, Duzallo nearly doubled the number of patients who achieved sUA target after 6 months.

The most common adverse events included headache, influenza, higher levels of blood creatinine, and heartburn. Additionally, Duzallo has a boxed warning regarding the risk of acute renal failure. It is not recommended for the treatment of asymptomatic hyperuricemia.

Duzallo contains lesinurad 200 mg plus allopurinol 300 mg. It is also available in a lesinurad 200 mg plus allopurinol 200 mg dosage. It should be taken in the morning with food and water, and patients should be advised to stay well hydrated when taking the medication.

According to the company’s press release, Duzallo is expected to be commercially available early in the fourth quarter of 2017.

Reference

Ironwood Pharmaceuticals announces FDA approval of Duzallo (lesinurad and allopurinol) for the treatment of hyperuricemia in patients with uncontrolled gout [news release]. Massachusetts. Ironwood Pharmaceuticals’ website. http://news.ironwoodpharma.com/phoenix.zhtml?c=228069&p=irol-newsArticle&ID=2294774. Accessed August 21, 2017.