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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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