Watson Announces Positive Data for Its Investigational Oxybutynin Topical Gel for the Treatment of Overactive Bladder at SUNA's Annual Conference
- New Research shows that oxybutynin topical gel may be a convenient alternative to currently available treatments for OAB -
CORONA, Calif., Oct. 8, 2008 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that investigators presented clinical pharmacokinetic data on oxybutynin chloride topical gel (OTG), its investigational therapy for overactive bladder (OAB).
Previously, the efficacy and safety of OTG were demonstrated in a Phase 3 multi-center, double blind, placebo-controlled study. The study showed that daily treatment of a 1g dose of OTG for 12 weeks was superior to placebo at relieving OAB symptoms, based on patient urinary diaries, which demonstrated a reduction in incontinence episodes and urinary frequency, and an increase in void volume. Secondary endpoints indicated a significant positive effect of OTG treatment on quality-of-life. Treatment was well tolerated in the study with no treatment-related serious adverse events.
"A topical oxybutynin gel is a convenient option for treating OAB that is easy to use and offers a way to improve treatment compliance among patients," said Diane K. Newman, RNC, MSN, CRNP, FAAM, lead author and Co-Director of the Penn Center for Continence and Pelvic Health, Division of Urology, University of Pennsylvania. "Transdermal drug delivery through a topical gel is a widely accepted and effective technology in urology. Our data confirm that this particular gel can fit nicely into a busy woman's daily regimen, including showering and sunscreen use, without compromising efficacy." Clinical Data Presented at SUNA The data presented at the Society of Urologic Nurses and Associates (SUNA) Annual Conference are from three open-label, randomized studies in healthy men and women which showed that showering one hour or later, or the application of sunscreen 30 minutes before or after OTG application did not significantly alter the absorption and systemic blood levels of OTG. The data also found limited transference of the drug when treated people came into contact with their untreated partner.
The new abstract included data from three open-label, randomized studies conducted in healthy men and women. In the showering study, participants received OTG for 35 days. Every seven days, starting at day 14, subjects either didn't shower or showered at 1, 2, or 6 hours after dosing. At the time points tested, showering did not have a meaningful impact on delivery of the drug into the bloodstream.
In the sunscreen study, participants received OTG alone, or 30 minutes before or after applying sunscreen. All three application regimens resulted in similar oxybutynin absorption and time to maximum blood plasma concentration (Tmax).
In these studies, OTG demonstrated good safety and tolerability. No treatment-related adverse events were observed, and no skin reactions to the gel application site were exhibited. In addition, there were no significant changes in vital signs among any of the trial participants between pre- and post-study evaluations.
"We are very excited about the new data, which further point to the outstanding convenience and ease-of-use of OTG, our topical gel formulation of oxybutynin, for patients suffering from OAB," said Edward Heimers, Jr., Executive Vice President and President of Watson's Brand division. "Through products like OTG, Watson continues to work to meet the highest standards of safety and efficacy while offering novel treatment solutions that allow patients to focus on enjoying their lives." About Oxybutynin Topical Gel (OTG) OTG is a clear, rapid-drying, odorless formulation of oxybutynin hydrochloride that is under development for the treatment of OAB with symptoms of urge urinary incontinence, urgency and frequency. It is designed to deliver a consistent dose of oxybutynin through the skin over a 24-hour period to help decrease urinary urgency and the frequency of incontinence episodes in patients with OAB. A one-gram (approx. 1 mL) dose of 100mg/g OTG, applied once daily, delivers about 4mg oxybutynin each day.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes generic and specialty brand pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
The mission of Watson Urology is to offer products and services that improve the quality of patients' lives, and satisfy the needs of physicians who specialize in the diagnosis, management, and treatment of urological disorders. By advancing education and support for urological diseases, we are creating the differences that make life more livable.
In the U.S., the Watson Urology portfolio includes: Oxytrol(R); TRELSTAR(R) LA; TRELSTAR(R) Depot; Androderm(R); ProQuin(R) XR, under a co-promotion agreement with Depomed, Inc.; and AndroGel(R), under a co- promotion agreement with Solvay Pharmaceuticals, Inc. In addition to oxybutynin topical gel, the Watson portfolio includes a number of products under development including: Rapaflo(TM)(silodosin), a product for the treatment of benign prostatic hyperplasia; and a six-month formulation of TRELSTAR(R) (triptorelin pamoate for injectable suspension), for the treatment of advanced prostate cancer and Uracyst(TM), for cystitis.
Forward-Looking Statement Any statements contained in this press release that refer to future events or other non-historical facts 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, the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions, if any; whether the results of clinical trials for oxybutynin topical gel and other information will be sufficient to support approval by FDA or other regulatory authorities; patents and other intellectual property rights held by the Company and the ability to successfully enforce such rights against third parties; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; 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, 2007.
Posted: October 2008