Health & Medical Rheumatoid Arthritis

FDA Approval of Uloric Made It the First New Drug for Gout in 40 Years

Updated June 03, 2014.

What Is Uloric?


Uloric (febuxostat) is a drug used for the chronic management of hyperuricemia in gout. While it was in clinical trials, Uloric was known by its generic name, febuxostat.

How Does Uloric Work?


Uloric lowers serum uric acid levels by blocking xanthine oxidase -- the enyzme responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine (a natural-occurring purine derivative) to xanthine, and then to uric acid.

How Is Uloric Given?


The approved doses of Uloric are 40 mg and 80 mg to be given once daily. Uloric is an oral medication (taken by mouth).

How Has Uloric Performed in Clinical Trials?


In clinical trials, Uloric was found to be more effective than placebo or allopurinol -- the other medication used to treat hyperuricemia.

In a 6-month phase III trial -- the percentage of gout patients, who reduced their uric acid levels to desired levels below 6, was much higher for those taking 80 mg than for those taking 40 mg of Uloric.

What Side Effects and Warnings Have Been Associated With Uloric?


Uloric is indicated for chronic management of hyperuricemia in patients with gout. It is not recommended for people with asymptomatic hyperuricemia. Uloric should not be used by people already being treated with azathioprine (Imuran), mercaptopurine,and theophylline.

Liver function abnormalities, nausea, arthralgia, and rash are adverse reactions that occur in a small number of patients. Also, compared to allopurinol, Uloric was assocated with a higher rate of cardiovascular thromboembolic events -- but no direct causal relationship was identified.

Is Uloric FDA-Approved and Available?


On February 13, 2009, Uloric was approved by the FDA. Uloric is the first new treatment option in 40 years for patients who have hyperuricemia and gout, according to Takeda Pharmaceuticals North America, Inc.

You can find complete prescribing information for Uloric at http://www.uloric.com.

Sources:

FDA Approves ULORIC® (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout. Takeda Pharmaceuticals. February 13, 2009.
http://www.tpna.com/newsroom/press_release_detail.aspx?year=2009&id=151

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