- First and Only Topical Gel for OAB to Launch in U.S. Next Month -
CHICAGO, April 27 /PRNewswire-FirstCall/ -- Data to be presented at the American Urological Association's (AUA) Annual Conference show that GELNIQUE(TM) (oxybutynin chloride) 10% gel significantly improves symptoms of OAB and urinary urge incontinence in women with the condition. By the end of the 12-week study period, 27 percent of women treated with GELNIQUE achieved complete urinary continence versus 15.6 percent treated with placebo. There were no treatment-related serious adverse events.
GELNIQUE, the first and only topical gel for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and frequency, is a quick drying, clear and colorless, fragrance-free gel containing oxybutynin hydrochloride that is developed and marketed by Watson Pharmaceuticals, a leader in generic and specialty branded pharmaceuticals. The gel received approval from the U.S. Food and Drug Administration in January 2009 and will launch mid-May.
"Women suffering from OAB often experience severe symptoms at a younger age, so it's important that we have an effective treatment that is both well tolerated and convenient for our female patients," said Roger R. Dmochowski, M.D., professor of urologic surgery at Vanderbilt University Medical Center and director of the Vanderbilt Continence Center, in Nashville, who presented the new findings. "Our new data further confirm that for women with OAB, GELNIQUE is a novel treatment approach with strong efficacy and excellent tolerability."
OAB is characterized by a sudden, uncomfortable need to urinate with or without urge incontinence (urine leakage), and usually includes more frequent urination and nocturia (waking up more than once during the night to urinate). It affects as many as 34 million adults in the U.S. - more than diabetes or asthma. The U.S. OAB market currently exceeds $1.8 billion annually and continues to grow each year. More than an "inconvenience," OAB can be disabling and is associated with a marked decrease in health-related quality of life as well as higher rates of depression. The disease affects both men and women however, women experience more severe symptoms earlier in life.
AUA Data Results
The abstract examined results from a Phase 3 randomized, double-blind, placebo-controlled, parallel group trial that evaluated a total of 789 men and women with signs and symptoms of OAB. The current analysis included data from the 704 female participants. During the 12-week trial, patients were treated with either one-gram of GELNIQUE or placebo applied once daily to specific sites on the skin.
Overall, women treated with GELNIQUE (n=352) versus placebo (n=352) reported a greater mean reduction in incontinence episodes (-3.0 vs. -2.5, P<0.0001), the study's primary endpoint. On secondary measures, GELNIQUE significantly reduced mean daily urinary frequency (-2.8 vs. -2.0 for placebo, P<0.0013) and increased mean urine void volume (22.7 vs. 4.0 for placebo, P<0.0006). The treatment was well tolerated in the study with a low incidence of adverse events and no treatment-related serious adverse events. The most frequently reported treatment-related adverse events (>2% and greater than placebo) were dry mouth (7.4% vs. 2.8% for placebo) and application-site pruritus (2.3% vs. 0.9% for placebo). Only two women treated with GELNIQUE and one treated with placebo withdrew primarily because of an application-site reaction.
About GELNIQUE
GELNIQUE is a quick-drying, clear and colorless, fragrance-free hydroalcoholic gel containing oxybutynin chloride, an antispasmodic antimuscarinic agent. Applied once daily to the thigh, abdomen, upper arm or shoulder, a one-gram (approx. 1 mL) dose of 100mg/g GELNIQUE consistently delivers a consistent dose of oxybutynin through the skin over a 24-hour period, providing strong efficacy with excellent tolerability.
Because the active ingredient in GELNIQUE is delivered transdermally, it is not metabolized in the same way as orally administered oxybutynin. It bypasses fist-pass metabolism, which reduces the formation of the N-desethyloxybutynin metabolite (N-DEO), which may be linked to unwanted side effects such as dry mouth and constipation. In clinical trials, GELNIQUE users reported low levels of dry mouth (6.9%) and constipation (1.3%).
In a Phase 3, 12-week trial, one-gram, once-daily GELNIQUE was superior to placebo at relieving OAB symptoms, including a reduction in incontinence episodes and urinary frequency, and an increase in urine void volume. The treatment was well tolerated in the study with a low incidence of adverse events and no treatment-related serious adverse events. The most frequently reported treatment-related adverse events (>2% and greater than placebo) were dry mouth and application-site reactions (5.4%).
Additional pharmacology studies showed that showering one hour or later, or applying sunscreen 30 minutes before or after GELNIQUE application, did not significantly alter the absorption of the drug.
For full prescribing information, please visit www.gelnique.com.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of branded pharmaceuticals focused on Urology, Gynecology and Nephrology (Medical).
In the U.S., the Watson portfolio includes RAPAFLO, GELNIQUE, TRELSTAR(R) LA and TRELSTAR(R) Depot, Ferrlecit(R), INFeD(R) and Oxytrol(R). In addition, Watson markets the following brands under co-promotion agreements: AndroGel(R), with Solvay Pharmaceuticals, Inc., and Femring(R), with Warner Chilcott Limited. The Watson pipeline portfolio includes a number of products, including a six-month formulation of TRELSTAR(R), for the treatment of advanced prostate cancer which is currently under review by the FDA; URACYST(R), under development for cystitis; and a novel new oral contraceptive.
For press releases and other company information, visit the Watson website at http://www.watson.com.
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 impact of competitive products and pricing; market acceptance of and continued demand for Watson's products, including GELNIQUE; difficulties or delays in manufacturing; patents and other intellectual property rights held by the Company and the ability to successfully enforce such rights against third parties; 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, 2008.
CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611;
or Lori Shachtman of Ogilvy Public Relations, +1-847-975-2330
Web site: http://www.watson.com/
