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Uloric (Febuxostat) - Summary

 



ULORIC SUMMARY

ULORIC (febuxostat) is a xanthine oxidase inhibitor.

ULORIC® is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.


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NEWS HIGHLIGHTS

Media Articles Related to Uloric (Febuxostat)

For Management Of Hyperuricemia In Patients With Gout, Uloric (Febuxostat) Demonstrated Efficacy
Source: Gout News From Medical News Today [2009.10.21]
Additional analysis showed that reduction and long-term maintenance of normal serum urate levels also reduced risk of future gout flares Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to

ULORIC(R) (febuxostat) Demonstrated Efficacy For Management Of Hyperuricemia In Patients With Gout
Source: Gout News From Medical News Today [2009.10.19]
Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to

FDA OKs New Gout Drug Uloric
Source: MedicineNet allopurinol Specialty [2009.02.17]
Title: FDA OKs New Gout Drug Uloric
Category: Health News
Created: 2/17/2009
Last Editorial Review: 2/17/2009

FDA Approves ULORIC(R) (febuxostat) For The Chronic Management Of Hyperuricemia In Patients With Gout
Source: Gout News From Medical News Today [2009.02.16]
Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced today that the United States Food and Drug Administration (FDA) has approved ULORIC(R) (febuxostat) 40 mg and 80 mg for the chronic management of hyperuricemia in patients with gout.

ASN: Febuxostat Works in Gout Patients with Renal Impairment (CME/CE)
Source: MedPage Today Rheumatology [2009.11.02]
SAN DIEGO (MedPage Today) -- In patients with gout and preexisting mild to moderate renal impairment, febuxostat (Uloric) is more effective and as safe as allopurinol, the gold standard gout treatment, researchers found.

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Published Studies Related to Uloric (Febuxostat)

Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study. [2009.02]
OBJECTIVES: This 5-yr study assessed urate-lowering and clinical efficacy and safety of long-term febuxostat therapy in subjects with gout. The primary efficacy end-point was reduction to and maintenance of serum urate (sUA) levels < 6.0 mg/dl... CONCLUSIONS: Long-term treatment with febuxostat resulted in durable maintenance of sUA < 6.0 mg/dl for most subjects. There was nearly complete abolition of gout flares in patients completing the study. Baseline tophi resolved in a majority of subjects.

Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. [2008.11.15]
OBJECTIVE: To compare the urate-lowering efficacy and safety of febuxostat, allopurinol, and placebo in a large group of subjects with hyperuricemia and gout, including persons with impaired renal function... CONCLUSION: At all doses studied, febuxostat more effectively lowered and maintained serum urate levels <6.0 mg/dl than did allopurinol (300 or 100 mg) or placebo in subjects with hyperuricemia and gout, including those with mild to moderately impaired renal function.

Effect of food or antacid on pharmacokinetics and pharmacodynamics of febuxostat in healthy subjects. [2008.03]
What is already known about this subject. Febuxostat is a novel nonpurine selective inhibitor of xanthine oxidase. What this study adds. This is the first manuscript to address the effect of food and antacid on the pharmacokinetics and/or pharmacodynamics of febuxostat. The study will determine whether the drug can be administered regardless of food or antacid. It will therefore influence how the drug should be administered. AIMS: To evaluate the effects of food or antacid on the pharmacokinetics and/or pharmacodynamics of febuxostat... CONCLUSIONS: Even though food caused a decrease in the rate and extent of absorption of febuxostat, this decrease was not associated with a clinically significant change in febuxostat pharmacodynamic effect. Despite a decrease in the absorption rate of febuxostat, antacid had no effect on the extent of febuxostat absorption. Therefore, febuxostat can be administered regardless of food or antacid intake.

Febuxostat. [2008]
*Febuxostat is an orally administered, non-purine, selective inhibitor of xanthine oxidase approved for the management of chronic hyperuricaemia in patients with gout. *In a randomized, double-blind, dose-ranging study in patients with gout and hyperuricaemia, significantly more recipients of febuxostat 40-120 mg/day than placebo had serum urate levels of < 6.0 mg/dL after 4 weeks of treatment...

Clinical efficacy and safety of successful longterm urate lowering with febuxostat or allopurinol in subjects with gout. [2009.06]
OBJECTIVE: To determine longterm urate-lowering efficacy and clinical benefits and safety of therapy with febuxostat or allopurinol in subjects with gout... CONCLUSION: Durable maintenance of goal range SUA level with either dose of febuxostat or in smaller numbers of subjects with allopurinol resulted in near elimination of gout flares and improved tophus status over time. Registered as NCT00175019.

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Page last updated: 2009-11-02

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