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New, Published GELNIQUE Data Show Efficacy, Convenience and Excellent Tolerability
Date:3/16/2009

CORONA, Calif., March 16 /PRNewswire-FirstCall/ -- New Phase 3 data, published in the April issue of The Journal of Urology, show that GELNIQUE(TM) (oxybutynin chloride) Gel 10%, the first and only topical gel approved for the treatment of overactive bladder (OAB), is effective at improving the symptoms of urge urinary incontinence, urgency and frequency, and is extremely well tolerated in adults.

GELNIQUE is a quick drying, clear and colorless, fragrance-free gel containing oxybutynin hydrochloride developed and marketed by Watson (NYSE: WPI), a leader in generic and specialty branded pharmaceuticals. Because the active ingredient in GELNIQUE is delivered transdermally, it is not metabolized by the liver in the same way as orally administered oxybutynin. This unique dosing results in a low level of side effects, such as dry mouth and constipation.

"The study data reveal that this innovative gel formulation provides the highly desired combination of efficacy and tolerability when utilized to treat symptoms of overactive bladder," said David R. Staskin, MD, associate professor of urology at Tufts University School of Medicine and Caritas - St. Elizabeth's Medical Center and lead author of the study. "GELNIQUE has the potential to be a very important option for the treatment of patients who suffer from problems with bladder control."

Clinical Data

The double-blind, placebo-controlled study included 789 men and women with urge-predominant urinary incontinence (UI) from 76 clinics across the U.S. Patients reported a mean 5.4 daily UI episodes and a mean daily urinary frequency of 12.2-12.4. The majority of participants were women (89.2 percent).

Patients were randomized to receive either 1 gram of GELNIQUE (n=389) or a matching placebo gel (n=400) once daily fo
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SOURCE Watson Pharmaceuticals, Inc.
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