Zurampic made available in US for patients with gout

Ironwood Pharmaceuticals Inc. announced Zurampic is now available in the United States, according to a company press release.

The FDA approved Zurampic (lesinurad, Ironwood) as a once-daily oral tablet taken in combination with allopurinol for the treatment of hyperuricemia — defined as high serum uric acid (sUA) levels — associated with gout in patients who could not previously achieve target sUA levels with allopurinol monotherapy. According to the release, the drug increases kidney secretion of uric acid by inhibiting URAT1, the transporter responsible for most uric acid re-absorption. Conversely, allopurinol reduces uric acid production by inhibiting xanthine oxidase. Together, the drugs treat hyperuricemia by lowering sUA levels.

Three phase 3 trials of patients with hyperuricemia and gout established the safety and efficacy of lesinurad. The multicenter trials lasted 12 months. Two of the trials assessed lesinurad in combination with allopurinol, while the third trial assessed it in combination with febuxostat, which is also a xanthine oxidase inhibitor. In the two trials with allopurinol, lesinurad almost doubled the number of patients who achieved their target sUA at month 6 and helped maintain the average sUA below the target level for all 12 months. In the trial with febuxostat, lesinurad helped more patients with tophaceous gout achieve their target sUA at month 6 and maintain it through month 12, but this increase was not statistically significant.

Acute renal failure was one of the adverse effects and occurred more often for lesinurad as monotherapy. The most common adverse events were headache, influenza, blood creatinine increase and gastroesophageal reflux disease. For these reasons, lesinurad is not recommended for asymptomatic hyperuricemia and should not be used as monotherapy.

Reference:

http://news.ironwoodpharma.com/phoenix.zhtml?c=228069&p=irol-newsArticle&ID=2208355