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www.renalandurologynews.com MARCH 2009 Renal & Urology News 17 Industry News FDA UPDATE AND PRODUCT NEWS FDA Update Product News I Topical Gel for Overactive Bladder Cleared Gelnique (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment New Drug Approved to Treat of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, has received FDA approval. Marketed by Watson Pharmaceuticals, Inc., Hyperuricemia in Gout Patients of Corona, Calif., Gelnique has been shown in a 12-week phase 3 trial to provide ease, Data show superiority of febuxostat over allopurinol efficacy, and excellent tolerability and will give OAB patients an effective and novel A NEW oral medication that re- ately impaired renal function, re- alternative to current oral treatment options. Because the drug’s active ingredient is duces serum uric acid levels has searchers found that febuxostat was delivered transdermally, it is not metabolized by the liver in the same way as orally received FDA approval for treating superior to allopurinol at the dosages administered oxybutynin. This lowers the incidence of side effects, such as dry mouth hyperuricemia in patients with gout. studied, according to a report in and constipation. The company expects to make Gelnique available to patients in the The drug, febuxostat (ULORIC, Arthritis & Rheumatism (2008;59: second quarter of this year. Takeda Pharmaceuticals), is the 1540-1548). In that study, 1,072 pa- first new treatment option for this tients with serum uric acid levels of I Blood Glucose Monitoring System Okayed patient population in 40 years. The 8 mg/dL or higher were random- The Glucocard 01-mini Blood Glucose Monitoring approved doses are 40 mg and ized to receive febuxostat (80 mg, System from Arkray USA, Inc., of Minneapolis, the only 80 mg. The drug is not recom- 120 mg, or 240 mg), allopurinol (100 such system that features interchangeable faceplates mended for managing asymptomatic or 300 mg, depending on renal func- so users can personalize the look of their monitor, has hyperuricemia. tion), or placebo for 28 weeks. The Febuxostat is contraindicated in primary end point was a serum uric received marketing clearance. This new system was patients taking azathioprine, mercap- acid level below 6 mg/dL for the last developed to use the same affordable test strips as topurine, and theophylline. three monthly measurements. In the the downloadable Glucocard 01 system that launched The drug lowers serum uric acid 80, 120, and 240 mg febuxostat in 2008. The mini version displays results in seven sec- levels by blocking xanthine oxidase, groups, 48%, 65%, and 69% of pa- onds, requires no coding, and features an easy-to-read an enzyme that breaks down hypo- tients achieved the primary end point display. “The Glucocard 01-mini system follows the xanthine, a purine base, to xanthine compared with 22% of allopurinol- brand image of sleek, compact, and discreet,” said and then to uric acid. treated subjects and 0% of place- Jonathan Chapman, president of Arkray USA, Inc. In a large phase 3 clinical trial, bo recipients. “An assortment o
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