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Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing by FDA for the Treatment of Overactive Bladder
Date:5/28/2008

CORONA, Calif., May 28 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that its New Drug Application (NDA) for oxybutynin chloride topical gel (OTG), has been accepted for filing by the U.S. Food and Drug Administration (FDA). Watson is seeking marketing approval of this novel transdermal gel of oxybutynin hydrochloride for the treatment of overactive bladder (OAB).

OTG is a clear, rapid-drying gel designed to produce consistent oxybutynin concentrations over a 24-hour period. By administering oxybutynin through the skin, OTG avoids first pass metabolism and the resultant high metabolite levels seen with oral oxybutynin dosing. A nickel-sized, one-gram unit dose of OTG, applied once daily, delivers about 4mg oxybutynin each day.

"Innovative products like OTG represent Watson's ongoing focus on developing effective, safe and convenient treatments that help to improve patients' lives," said Ed Heimers, Jr., Executive Vice President and President of Watson's Brand Division. "We believe this new formulation of oxybutynin signifies an important advancement in treatment options for OAB as it offers the benefits of transdermal therapy with excellent skin tolerability."

The NDA filing for OTG is based on data from a Phase 3 randomized, double-blind, placebo-controlled study involving 789 patients with OAB. In the 12-week study, patients treated with OTG once daily experienced a highly significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day, a decrease in urinary frequency and an increase in the average urine volume per void. Significant improvements relative to placebo in quality of life, a
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SOURCE Watson Pharmaceuticals, Inc.
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