Allergan Inc. Release: Nearly Half Of Women In New Survey Reveal That Their Current Treatments Are Not Adequately Addressing Overactive Bladder (OAB) Symptoms
IRVINE, Calif., Aug. 19, 2014 /PRNewswire/ -- Nearly half (46 percent) of women age 45 or older who experience symptoms of overactive bladder (OAB) say their current treatment does not address their OAB symptoms, according to a recent survey (n=1,017) conducted by The Harris Poll on behalf of Allergan, Inc.1 An estimated 39 million Americans are currently living with OAB,2 a common, sometimes disabling condition3 often associated with a considerable impact on patients with symptoms that include a strong, sudden need to urinate and urinary frequency with or without leakage.
Nearly nine in 10 women surveyed report that OAB impacts their everyday life (86 percent),1 and about two in three women (64 percent) have used some kind of treatment to manage their OAB symptoms, most commonly pills prescribed by a physician (31 percent). Despite the impact of the condition, about one in five women (21 percent) worry about being perceived as a difficult patient if they are unhappy with a treatment plan.1
"In my specialty, I see firsthand the impact OAB can have on a person's daily activities from mapping the bathrooms on the way to work to having a wetting accident," said Courtenay Moore, M.D., Associate Professor, Cleveland Clinic Case Lerner College of Medicine. "While I appreciate that bladder leakage is a topic that might be uncomfortable to talk about and revisit, it's essential for patients to have a candid and continuous dialogue for their doctors to find the treatment that works for them."
Oftentimes, treatment begins with lifestyle changes such as reduction of fluid intake, decreased amounts of caffeine, bladder control strategies and pelvic floor muscle training. Anticholinergic medications, in the form of pills, are also often prescribed by physicians to manage OAB. In one study of 1,117 patients, the majority of patients (73.5 percent), however, stopped taking their pills within one year due to side effects and/or lack of results.4
"Unfortunately, too many women are settling and dealing with the symptoms of OAB because an anticholinergic medication hasn't worked well or has side effects that can't be tolerated. Specialists, such as urologists and urogynecologists, can offer additional options after pills," said Dr. Moore. "For example, BOTOX® (onabotulinumtoxinA) may be a treatment option for those who have tried another OAB medication and are still frustrated that their medication is not working or they can't tolerate the side effects. It's imperative for patients to share with me how their initial treatment regimen is working or not working, so we can work together in determining other treatment options."
In May, the American Urological Association (AUA) released updated treatment guidelines for OAB, which supports BOTOX® as an appropriate therapy to consider for the treatment of overactive bladder when self-management is not effective, and anticholinergic medications do not work well enough or are too difficult to tolerate.5
BOTOX® is approved to treat overactive bladder symptoms, such as a strong need to urinate with leakage, urgency and frequency in adults when another type of medication (anticholinergic) does not work well enough or cannot be taken.
BOTOX® treatment takes another approach to targeting OAB the bladder muscle itself. BOTOX® works by calming the nerves that trigger the overactive bladder muscle, helping to reduce daily leakage episodes, treat the strong need to urinate right away and reduce the number of times needed to empty the bladder daily.
To learn more about OAB, and to find a BOTOX® specialist, visit www.BOTOXforOAB.com.
About the Survey
The OAB Patient Survey was conducted by The Harris Poll on behalf of Allergan, Inc. in order to assess comfort levels discussing OAB among women who experience symptoms and uncover potential barriers to treatment. The survey was administered online within the United Statesbetween April 3 and 18, 2014, among 1,017 women age 45 or older who report experiencing symptoms of overactive bladder. Data were weighted where necessary by age, income, education, race/ethnicity, and propensity to be online to bring them in line with their actual proportions in the population.
About Nielsen & The Harris Poll
On February 3, 2014, Nielsen acquired Harris Interactive and The Harris Poll. Nielsen Holdings N.V. is a global information and measurement company with leading market positions in marketing and consumer information, television and other media measurement, online intelligence and mobile measurement. Nielsen has a presence in approximately 100 countries, with headquarters in New York, USA and Diemen, the Netherlands. For more information, visit www.nielsen.com.
BOTOX® (onabotulinumtoxinA) Important Information
Indication
BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into the bladder muscle and used to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities
Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Do not take BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post-treatment, if required, should be considered for treatment.
In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo.
Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.
The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. These reactions include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX® should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX®.
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).
Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.
About Allergan
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 11,700 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. For more information regarding Allergan, go to: www.allergan.com.
Forward-Looking Statements
This press release contains "forward-looking statements" including but not limited to the statements by Dr. Moore, as well as other statements regarding the research and development, safety, efficacy, adverse reactions, and other statements regarding the use of BOTOX® for the treatment of overactive bladder. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; challenges related to achieving regulatory approval from the FDA on a timely and cost-efficient manner; technological advances and patents attained by competitors; inconsistency of treatment results among patients; potential difficulties in manufacturing; challenges related to new product marketing, such as the unpredictability or market acceptance for new products and/or the acceptance of new indications for such products; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by Allergan, as well as Allergan's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. Copies of Allergan's press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
©2014 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc. All rights reserved.
Myobloc®is a registered trademark of Solstice Neuroscience, Inc.
Dysport®is a registered trademark of Ipsen Biopharm, Ltd.
Xeomin®is a registered trademark of Merz Pharma Gmbh & Co.
APC36IF14
1 Harris Poll Women and Overactive Bladder Survey, Allergan, 2014. The Overactive Bladder Survey was conducted between April 3rd and April 18th, 2014 among 1,017 nationally representative American women ages 45 and older, using an email invitation and an online survey.
2 Data on File
3 Tubaro A. Defining overactive bladder: epidemiology and burden of disease. Urology. 2004. Dec;64(6 Suppl 1):2-6.
4 D'Souza AO et al. J Manag Care Pharm. 2008;14(3):291-301.
5 Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline. May 2014. Available at: http://www.auanet.org/common/pdf/education/clinical-guidance/Overactive-Bladder.pdf.
SOURCE Allergan, Inc.