FDA Approves OXYTROL FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women

Fri Jan 25, 2013 11:10am EST

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New Over-the-Counter Option for More Than 20 Million Women with Overactive
Bladder
WHITEHOUSE STATION, N.J.,  Jan. 25, 2013  /PRNewswire/ -- Merck (NYSE: MRK),
known as MSD outside  the United States  and  Canada, announced today that the
U.S. Food and Drug Administration (FDA) has approved OXYTROL FOR WOMEN
(oxybutynin transdermal system, 3.9 mg/day), the first and only over-the-counter
(OTC) treatment for overactive bladder in women. OXYTROL FOR WOMEN addresses an
important unmet need for overactive bladder, or OAB, a condition that affects
more than 20 million American women. Despite the fact that OAB is a treatable
medical condition, more than 80 percent of women with OAB do not seek treatment.

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OAB is characterized by a number of symptoms that can be physically burdensome
and emotionally draining, including a strong urge to urinate right away and the
need to urinate more often than usual, with or without leakage. The majority of
women who suffer develop the condition between the ages of 45 and 60 years old. 
According to the National Association for Continence, although OAB is a
treatable medical condition, most women do not discuss their symptoms with a
doctor and assume that the symptoms are a normal part of aging.  Rather than
seek treatment, many women try to manage their condition with coping strategies
that include wearing pads and/or dark clothing, mapping out the nearest toilets,
and avoiding social interactions outside the home.

"The approval of OXYTROL FOR WOMEN as an OTC treatment option is an exciting
development for the millions of women who struggle to deal with OAB every day,"
said  Eman Elkadry, M.D., Clinical Instructor Harvard Medical School; Boston
Urogynecology Associates at Mount Auburn Hospital. "This effective,
over-the-counter treatment offers women an option to independently manage their
condition and achieve a newfound sense of control. The approval also provides
recognition that this is a real medical disorder that can be addressed."  

The FDA approval of the prescription to OTC switch was based on data from
several well-designed studies that demonstrated a woman's ability to correctly
recognize OAB symptoms, understand key safety messages on the label, judge if
the product is right, or wrong, for her, and appropriately use OXYTROL FOR WOMEN
in an unsupervised setting.  The FDA considers this a partial switch, as OXYTROL
will remain available by prescription only for the treatment of OAB in men. The
approval follows an FDA Advisory Committee meeting that occurred in  November
2012.  

"Merck is dedicated to increasing access to safe and effective treatments to
help people better manage their health conditions and improve the quality of
their lives," said  Bridgette P. Heller, Executive Vice President and President,
Merck Consumer Care.  "We are proud to bring OXYTROL FOR WOMEN over-the-counter
and provide a treatment option that can help women with OAB recognize and treat
their symptoms."

Merck anticipates that OXYTROL FOR WOMEN will be available to customers in Fall
2013.

Please visit  www.OxytrolForWomen.com  for more information.  

About OXYTROL®  FOR WOMEN  

OXYTROL®  FOR WOMEN is the only over-the-counter treatment available for
overactive bladder in women. The OXYTROL FOR WOMEN patch provides transdermal
delivery of oxybutynin, an active ingredient used to treat OAB for more than 30
years. Each OXYTROL FOR WOMEN patch delivers 3.9 mg of oxybutynin per day for a
continuous four days and nights­­.  

Merck licensed the exclusive rights to market, distribute and sell OXYTROL as an
OTC treatment for OAB from Actavis, Inc. (NYSE: ACT), formerly known as Watson
Pharmaceuticals, Inc.

OXYTROL®  (oxybutynin transdermal system) is a registered trademark of Watson
Pharma, Inc.

About Merck Consumer Care  

Today's Merck is a global healthcare leader working to help the world be well. 
Merck Consumer Care is a subsidiary of Merck & Co., Inc.  Each day, millions
count on one or more of our industry-leading brands that help prevent or treat
various common conditions.  These include household names such as CLARITIN®  for
allergies, COPPERTONE®  for sun care, DR. SCHOLL'S®  for foot care, and many
more.  For more information, visit  www.merck.com  and connect with us on 
Twitter,  Facebook  and  YouTube.

Merck Forward-Looking Statement

This news release includes "forward-looking statements" within the meaning of
the safe harbor provisions of the United States Private Securities Litigation
Reform Act of 1995.  Such statements may include, but are not limited to,
statements about the benefits of the merger between Merck and Schering-Plough,
including future financial and operating results, the combined company's plans,
objectives, expectations and intentions and other statements that are not
historical facts.  Such statements are based upon the current beliefs and
expectations of Merck's management and are subject to significant risks and
uncertainties.  Actual results may differ from those set forth in the
forward-looking statements.

The following factors, among others, could cause actual results to differ from
those set forth in the forward-looking statements: the possibility that all of
the expected synergies from the merger of Merck and Schering-Plough will not be
realized, or will not be realized within the expected time period; the impact of
pharmaceutical industry regulation and health care legislation in  the United
States  and internationally; Merck's ability to accurately predict future market
conditions; dependence on the effectiveness of Merck's patents and other
protections for innovative products; and the exposure to litigation and/or
regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise.  Additional
factors that could cause results to differ materially from those described in
the forward-looking statements can be found in Merck's 2011 Annual Report on
Form 10-K and the company's other filings with the Securities and Exchange
Commission (SEC) available at the SEC's Internet site (www.sec.gov).




SOURCE  Merck Consumer Care


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