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Oxybutynin Transdermal System Now Available Nationwide
CORONA, Calif., April 28 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today announced that OXYTROL™ (oxybutynin transdermal system), the first and only transdermal therapy to treat overactive bladder (OAB), with symptoms of urge urinary incontinence, urgency and frequency, is now available nationwide, having shipped to more than 45,000 major pharmacy chain and independent stores. OXYTROL™ was approved by the U.S. Food and Drug Administration (FDA) in late February 2003. Watson has priced OXYTROL™ at a 10% discount as compared to the Wholesale Acquisition Cost (WAC) for the most widely prescribed extended release OAB branded products, specifically Detrol® LA, 4mg and Ditropan XL®, 10mg.
"OXYTROL™ offers patients the powerful efficacy of oxybutynin in a convenient twice-weekly transdermal patch," stated Joseph C. Papa, Watson's President and Chief Operating Officer. "The difference in anticholinergic side effect profiles between OXYTROL™ and placebo is not statistically significant."
Clinical trials involving approximately 1,000 subjects at more than 50 U.S. centers demonstrated that Watson's OXYTROL™ product, with its unique transdermal delivery system, provides effective control of OAB symptoms over a three to four day period. Data also shows that OXYTROL™ is well tolerated, with a low incidence of anticholinergic side effects including dry mouth, constipation and dizziness. The most commonly reported adverse events with OXYTROL™ were application site reactions, dry mouth, constipation, diarrhea, dysuria and abnormal vision.
OXYTROL™ is a thin, flexible and clear patch that should be applied to the abdomen, hip or buttock twice weekly. The active ingredient in OXYTROL™ is oxybutynin, a medication widely accepted and prescribed in oral formulation for the past 25 years. OXYTROL's™ transdermal delivery system delivers 3.9 milligrams per day of oxybutynin consistently and continuously through the skin into the bloodstream, bypassing initial metabolism in the liver and the gastrointestinal tract that occurs with oral medications, providing relief of overactive bladder symptoms for up to four days. Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to oxybutynin or other components of OXYTROL™ should not use OXYTROL™. For full prescribing information on OXYTROL™, please call 1-888-OXYTROL (1-888-699-8765).
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets and distributes branded and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watsonpharm.com/.
Statements contained in this press release that refer to future events or other non-historical facts about Watson are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, market acceptance of and continued demand for Watson's products, including the impact of competitive products and pricing; patents and other intellectual property rights held by competitors and other third parties; successful compliance with governmental regulations; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2002.
Detrol® and Ditropan XL® are registered trademarks of Pharmacia & UpJohn S.A. Corporation and Alza Corporation, respectively.