/C O R R E C T I O N -- Watson Pharmaceuticals, Inc./
March 17 2009 - 12:59PM
PR Newswire (US)
In the news release, New, Published GELNIQUE Data Show Efficacy,
Convenience and Excellent Tolerability, issued yesterday, March 16,
by Watson Pharmaceuticals, Inc. (NYSE: WPI) over PR Newswire, the
numbers in the sixth paragraph were transmitted incorrectly. The
complete, corrected release follows. CORONA, Calif., March 16
/PRNewswire-FirstCall/ -- New Phase 3 data, published in the April
issue of The Journal of Urology, show that GELNIQUE(TM) (oxybutynin
chloride) Gel 10%, the first and only topical gel approved for the
treatment of overactive bladder (OAB), is effective at improving
the symptoms of urge urinary incontinence, urgency and frequency,
and is extremely well tolerated in adults. GELNIQUE is a quick
drying, clear and colorless, fragrance-free gel containing
oxybutynin hydrochloride developed and marketed by Watson (NYSE:
WPI), a leader in generic and specialty branded pharmaceuticals.
Because the active ingredient in GELNIQUE is delivered
transdermally, it is not metabolized by the liver in the same way
as orally administered oxybutynin. This unique dosing results in a
low level of side effects, such as dry mouth and constipation. "The
study data reveal that this innovative gel formulation provides the
highly desired combination of efficacy and tolerability when
utilized to treat symptoms of overactive bladder," said David R.
Staskin, MD, associate professor of urology at Tufts University
School of Medicine and Caritas - St. Elizabeth's Medical Center and
lead author of the study. "GELNIQUE has the potential to be a very
important option for the treatment of patients who suffer from
problems with bladder control." Clinical Data The double-blind,
placebo-controlled study included 789 men and women with
urge-predominant urinary incontinence (UI) from 76 clinics across
the U.S. Patients reported a mean 5.4 daily UI episodes and a mean
daily urinary frequency of 12.2-12.4. The majority of participants
were women (89.2 percent). Patients were randomized to receive
either 1 gram of GELNIQUE (n=389) or a matching placebo gel (n=400)
once daily for 12 weeks. GELNIQUE delivers a consistent dose of
oxybutynin through the skin over a 24-hour period. A 1-gram
(approx. 1 mL) daily dose delivers about 4 mg oxybutynin each day.
Patients applied GELNIQUE each day to rotating sites on the
abdomen, upper arm or shoulder and thigh. By week 12, the mean
number of episodes of urinary incontinence, the study's primary
endpoint, decreased significantly (p