OXYTROL® FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women, Now Available Nationwide

Offers More Than 20 Million Female Sufferers Newfound Sense of Control over Condition

Wednesday, September 25, 2013 8:32 am EDT

Dateline:

WHITEHOUSE STATION, N.J.

Public Company Information:

NYSE:
MRK
"It’s important for women to have access to a prescription-strength OTC option like OXYTROL FOR WOMEN because it offers them a convenient and cost-effective way to help manage their condition"

Merck Consumer Care, the makers of OXYTROL FOR WOMEN, announced today that the more than 20 million women suffering from overactive bladder (OAB) can now gain better control of their condition with a visit to the feminine care aisle at their local retailer. OXYTROL FOR WOMEN is a thin, flexible patch that is discreetly applied to the abdomen, hip or buttock once every four days for the relief of overactive bladder in women. It is the first and only over-the-counter option that treats the OAB symptoms – urinary incontinence, urgency and frequency – which can take a physical and emotional toll on women.

OAB is one of the top ten chronic conditions affecting American women, impacting various facets of their lives – such as travel, work productivity, emotional and physical wellbeing, as well as family relationships and social activities. In fact, more than one in three women (37 percent) with OAB reported that the condition affects their relationship with their partner and nearly half said they are worried about having a urinary accident in public (55 percent) or in the car (48 percent). In addition, recent data demonstrate the overall economic impact is estimated at $35 billion annually – both direct and indirect costs such as doctor visits, prescription medications and coping strategies like using pantiliners and pads, among others.

“It’s important for women to have access to a prescription-strength OTC option like OXYTROL FOR WOMEN because it offers them a convenient and cost-effective way to help manage their condition,” said Eman Elkadry, M.D., Clinical Instructor Harvard Medical School; Boston Urogynecology Associates at Mount Auburn Hospital and spokesperson for the makers of OXYTROL FOR WOMEN. “Women who suffer from OAB wait on average more than three years before seeking care – that’s why I’ve been an advocate for giving women an OTC choice so they can treat their symptoms and better manage their health.”

With an OTC option in hand and a lifestyle modification plan, female OAB sufferers can gain better control over OAB symptoms. By applying one patch every four days as directed, OXYTROL FOR WOMEN can provide women OAB symptom relief within two weeks when combined with daily lifestyle changes. These modifications include following a daily bathroom schedule, managing fluid intake and strengthening bladder muscles. Maintaining a healthy weight can also help, as excess weight can increase the pressure on the bladder and make OAB worse. The OXYTROL FOR WOMEN patch can be worn during everyday activities, including showering or exercising.

“Merck is proud to bring a first-in-class, over-the-counter OAB product for women to shelves nationwide,” said James Mackey, Senior Vice President and U.S. Region Head for Merck Consumer Care. “Leveraging our prescription-to-OTC switch experience to deliver greater access and value is another example of how Merck is committed to enhancing the quality of life for women.”

OXYTROL FOR WOMEN is now available at leading retailers. Please visit www.OxytrolForWomen.com for more information.

About Overactive Bladder (OAB)

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 (eight or more times a day), with or without leakage. Despite the fact that OAB is a treatable medical condition, more than 80 percent of women with the condition do not seek treatment.

Some women first experience OAB as early as their 30s, but the majority develop the condition between the ages of 45 and 64, with prevalence of OAB increasing as women age. 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.

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 for a continuous four days and nights and works by helping to relax the bladder muscle – to reduce the urgency, frequency and number of accidents associated with overactive bladder­­.

The FDA approval of the prescription-to-OTC switch on January 25, 2013 was based on data from 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.

Merck licensed the exclusive rights to market, distribute and sell OXYTROL FOR WOMEN in the U.S. 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 Actavis, 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. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck patents and other protections for innovative products; and the exposure to litigation, including patent 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 2012 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). 

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