- Bold and innovative marketing campaign will target women and highlight
product's efficacy, ease of use and excellent tolerability -
CORONA, Calif., May 21 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, a
leader in generic and specialty branded pharmaceuticals, announced today the
launch of GELNIQUE(TM) (oxybutynin chloride) gel 10%, first and only topical
gel for the treatment of overactive bladder (OAB) with symptoms of urge
urinary incontinence, urgency, and frequency.
While GELNIQUE is approved for use in men as well as women, Watson has
opted to target the active, female OAB patient in its marketing efforts. The
GELNIQUE marketing campaign will highlight the power of control GELNIQUE
offers to OAB patients rather than focusing, as traditional products have, on
the predictable embarrassment and stigma associated with OAB.
"As the first and only topical gel for OAB, we believe that GELNIQUE
provides physicians and their patients with an effective, easy first-line drug
treatment option," said Paul Bisaro, Chief Executive Officer of Watson.
"Because GELNIQUE is a first, we are launching our product with a unique
promotional campaign, one that speaks to health care professionals and
patients with language and images that are empowering. We believe we can
successfully position this new treatment option in a way that differentiates
our product, and our message in a category that has been dominated by big
pharma's tired and traditional promotion for years."
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 at least 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 is disabling
and 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.
In addition to GELNIQUE, Watson recently launched RAPAFLO(TM) (silodosin),
the Company's new alpha blocker for the treatment of the signs and symptoms of
benign prostatic hyperplasia (BPH), which offers rapid relief and has an
exceptional safety profile. The Company also has submitted a New Drug
Application for its 6-month formulation of TRELSTAR(R) (triptorelin pamoate),
a luteinizing hormone releasing hormone (LHRH) agonist for the palliative
treatment of advanced prostate cancer. Watson anticipates that FDA will take
action on this application in the third quarter 2009.
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, one-gram (approx. 1 mL) of GELNIQUE gel 10% 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 lotion 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., (NYSE: WPI) 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
For press releases and other company information, visit the Watson website
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;
the difficulty of predicting the timing or outcome of FDA approvals and
actions, if any; 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.
SOURCE Watson Pharmaceuticals, Inc.
Patty Eisenhaur of Watson Pharmaceuticals, Inc.,
or Lori Shachtman of Ogilvy Public Relations,
Web Site: http://www.watson.com