Watson Announces Positive Data for Its Investigational Oxybutynin Topical Gel for the Treatment of Overactive Bladder at SUNA's Annual Conference
Previously, the efficacy and safety of OTG were demonstrated in a Phase 3multi-center, double blind, placebo-controlled study. The study showed thatdaily treatment of a 1g dose of OTG for 12 weeks was superior to placebo atrelieving OAB symptoms, based on patient urinary diaries, which demonstrated areduction in incontinence episodes and urinary frequency, and an increase invoid volume. Secondary endpoints indicated a significant positive effect ofOTG treatment on quality-of-life. Treatment was well tolerated in the studywith no treatment-related serious adverse events.
"A topical oxybutynin gel is a convenient option for treating OAB that iseasy 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 thePenn Center for Continence and Pelvic Health, Division of Urology, Universityof Pennsylvania. "Transdermal drug delivery through a topical gel is a widelyaccepted and effective technology in urology. Our data confirm that thisparticular gel can fit nicely into a busy woman's daily regimen, includingshowering 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 menand women which showed that showering one hour or later, or the application ofsunscreen 30 minutes before or after OTG application did not significantlyalter the absorption and systemic blood levels of OTG. The data also foundlimited transference of the drug when treated people came into contact withtheir untreated partner.
The new abstract included data from three open-label, randomized studiesconducted in healthy men and women. In the showering study, participantsreceived OTG for 35 days. Every seven days, starting at day 14, subjectseither didn't shower or showered at 1, 2, or 6 hours after dosing. At the timepoints tested, showering did not have a meaningful impact on delivery of thedrug into the bloodstream.
In the sunscreen study, participants received OTG alone, or 30 minutesbefore or after applying sunscreen. All three application regimens resultedin similar oxybutynin absorption and time to maximum blood plasmaconcentration (Tmax).
In these studies, OTG demonstrated good safety and tolerability. Notreatment-related adverse events were observed, and no skin reactions to thegel application site were exhibited. In addition, there were no significantchanges in vital signs among any of the trial participants between pre- andpost-study evaluations.
"We are very excited about the new data, which further point to theoutstanding convenience and ease-of-use of OTG, our topical gel formulation ofoxybutynin, for patients suffering from OAB," said Edward Heimers, Jr.,Executive Vice President and President of Watson's Brand division. "Throughproducts like OTG, Watson continues to work to meet the highest standards ofsafety and efficacy while offering novel treatment solutions that allowpatients to focus on enjoying their lives."
About Oxybutynin Topical Gel (OTG)
OTG is a clear, rapid-drying, odorless formulation of oxybutyninhydrochloride that is under development for the treatment of OAB with symptomsof urge urinary incontinence, urgency and frequency. It is designed todeliver a consistent dose of oxybutynin through the skin over a 24-hour periodto help decrease urinary urgency and the frequency of incontinence episodes inpatients with OAB. A one-gram (approx. 1 mL) dose of 100mg/g OTG, applied oncedaily, delivers about 4mg oxybutynin each day.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading specialty pharmaceutical companythat develops, manufactures, markets, sells and distributes generic andspecialty brand pharmaceutical products. Watson pursues a growth strategycombining internal product development, strategic alliances and collaborationsand synergistic acquisitions of products and businesses.
The mission of Watson Urology is to offer products and services thatimprove the quality of patients' lives, and satisfy the needs of physicianswho specialize in the diagnosis, management, and treatment of urologicaldisorders. By advancing education and support for urological diseases, we arecreating 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 aco-promotion agreement with Depomed, Inc.; and AndroGel(R), under a co-promotion agreement with Solvay Pharmaceuticals, Inc. In addition tooxybutynin topical gel, the Watson portfolio includes a number of productsunder development including: Rapaflo(TM)(silodosin), a product for thetreatment of benign prostatic hyperplasia; and a six-month formulation ofTRELSTAR(R) (triptorelin pamoate for injectable suspension), for the treatmentof advanced prostate cancer and Uracyst(TM), for cystitis.
For press releases and other company information, visit WatsonPharmaceuticals' Web site at http://www.watson.com.
Any statements contained in this press release that refer to future eventsor other non-historical facts are forward-looking statements that reflectWatson's current perspective of existing trends and information as of the dateof this release. Except as expressly required by law, Watson disclaims anyintent or obligation to update these forward-looking statements. Actualresults may differ materially from Watson's current expectations dependingupon a number of factors affecting Watson's business. These factors include,among others, the difficulty of predicting the timing or outcome of productdevelopment efforts and FDA or other regulatory agency approvals or actions,if any; whether the results of clinical trials for oxybutynin topical gel andother information will be sufficient to support approval by FDA or otherregulatory authorities; patents and other intellectual property rights held bythe Company and the ability to successfully enforce such rights against thirdparties; the impact of competitive products and pricing; market acceptance ofand continued demand for Watson's products; difficulties or delays inmanufacturing; and other risks and uncertainties detailed in Watson's periodicpublic filings with the Securities and Exchange Commission, including but notlimited to Watson's Annual Report on Form 10-K for the year ended December 31,2007.
SOURCE Watson Pharmaceuticals, Inc.
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