Allergan's BOTOX® (botulinum toxin type A) Receives a Positive Opinion in Fourteen European Countries for Idiopathic Overactive Bladder
Data demonstrates BOTOX® injections can reduce urinary leakage episodes for up to six months in patients who have had an inadequate response to, or are intolerant of, anticholinergic medication
Marlow, UK, 19 December 2012 – Today, Allergan Inc. announced that BOTOX® has received a positive opinion from the Irish Medicines Board for the treatment of idiopathic overactive bladder (OAB) with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medications. This is an important step towards securing national licences in the 14 European countries involved in the Mutual Recognition Procedure and marks a key milestone in bringing this innovative treatment to patients suffering from idiopathic OAB. The positive opinion is specific for BOTOX® and is based on Allergan’s successful global phase III programme in idiopathic OAB.
Idiopathic overactive bladder is surprisingly common in Europe, with studies indicating that up to 16.6% of the population may have the condition.1,2 Of these, up to 36% will experience urinary incontinence (leaking) associated with urgency.1 Two multi-national studies report that between 16-28% of idiopathic OAB patients receive a prescription medication to manage their condition.3,4 However, research also indicates that more than 50% of patients stop taking at least one oral medication within 12 months, likely due to lack of efficacy or side-effects.5,6 Idiopathic OAB can be a disabling and socially isolating condition, considerably affecting daily activities, work-life, mental health and sleep quality, thus reducing patients’ quality of life.7 It can negatively impact emotional well-being causing embarrassment, low self esteem, depression and loss of independence.8
“We are pleased that BOTOX® has received a positive opinion from the Irish Medicines Board for the treatment of idiopathic OAB in patients who are struggling to control their bladder symptoms with anticholinergic medications. For these patients, gaining effective control over their bladder without the fear of leakage after only one treatment can be a significant step towards improving quality of life,” said Douglas Ingram, President of Allergan in Europe, Africa and the Middle East. “This is a critical milestone for the organisation, extending our commitment to urology beyond neurogenic detrusor overactivity and building on our long-term commitment to innovation in botulinum toxin research. Our task now is to work closely with the national health authorities in Europe to secure the relevant national licences so that we can bring this valuable treatment option to patients, as quickly as possible.”
The positive opinion is based on the results of two randomised, placebo-controlled, multi-centre, phase III trials (the EMBARK studies) involving over 1,100 patients.9 In these studies, patients who received targeted injections of BOTOX® (100 Units) into the bladder muscle experienced a significant and clinically relevant response to treatment compared to placebo in the reduction of urinary incontinence, including more patients becoming dry (no urinary leakage at 12 weeks). Significant improvements compared with placebo were also observed for all other symptoms of idiopathic OAB. Patients treated with Allergan’s botulinum toxin type A product reported significant improvements in their quality of life compared to patients treated with placebo. In these studies, Allergan’s botulinum toxin type A product was generally well tolerated. The most common adverse events reported were urinary tract infection and dysuria (painful urination).9
“There are currently very limited treatment options for idiopathic OAB patients who have not achieved bladder control with existing anticholinergic medications. Many patients find these daily medications are difficult to adhere to and sometimes have limited effect, and they continue to live with the potentially debilitating impact of their condition,” said Professor Christopher Chapple, Urology Department, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust and a key investigator in the idiopathic overactive bladder registration trials. “There is a need for additional treatments that are effective, well-tolerated, minimally invasive options to help patients gain better control of these distressing symptoms.”
Notes to Editors
Countries involved in the Mutual Recognition Procedure (MRP)
For BOTOX®, Ireland serves as the Reference Member State in the Mutual Recognition Procedure. The other countries involved are Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Italy, Luxemburg, Norway, Portugal, Spain, and Sweden.
About Idiopathic Overactive Bladder
While the exact cause is often unknown, idiopathic overactive bladder (iOAB) is a medical condition where involuntary contractions of the bladder can cause an uncontrolled urge to urinate (urgency), frequent urination (frequency) and unexpected leakage of urine (urinary incontinence).
BOTOX® (botulinum toxin type A) from Allergan is a prescription-only medicine that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. Allergan’s botulinum toxin type A product received the first licence from the US Food and Drug Administration in 1989 and is now available in approximately 85 countries. Worldwide, approximately 30 million vials of Allergan’s botulinum toxin type A products have been distributed over the past 20 years (1990-2010). The safety and efficacy of BOTOX® has been well-established with approximately 65 randomized, placebo-controlled clinical trials involving approximately 15,000 patients, and with more than 2,500 articles in scientific and medical journals, Allergan’s neurotoxin is one of the most widely researched medicines in the world.10
Allergan, Inc. 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 more than 10,500 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, over-the-counter medicines and medical devices, 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 ophthalmology, neurosciences, obesity, urologics, medical aesthetics and dermatology, 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.
This press release contains "forward-looking statements", including but not limited to the statements by Mr. Ingram, Professor Christopher Chapple and other statements regarding research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding idiopathic overactive bladder and BOTOX®. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2010 Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.
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- Milsom I et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU International, 2001;87;760-766
- Irwin DE. et al. Population-Based Survey of Urinary Incontinence, Overactive Bladder, and Other Lower Urinary Tract Symptoms in Five Countries: Results of the EPIC Study. European Urology, 2006;50: 1306–1315
- Reeves P et al. The current and future burden and cost of overactive bladder in five European countries. European Urology, 2006; 50: 1050-1057
- Cruz F et al. Patient attitudes and patterns of treatment utilization in a European population with overactive bladder symptoms. Eur Urol. 2012;11(Suppl 1):e577
- Pelletier EM et al. Pharmacotherapy adherence and costs versus nonpharmacologic management in overactive bladder. Am J Manag Care 2009;15:S108–14
- D’Souza A et al. Persistence, adherence and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. JMCP, 2008; 14: 291-301
- Tubaro A. Defining Overactive bladder: Epidemiology and burden of disease. Urology, 2004; 64 (Suppl 6A): 2-6
- NIH Consensus and State-of-the-Science Statements, Prevention of Fecal and Urinary Incontinence in Adults. Dec 12-14 2007:24(1):1-37 http://consensus.nih.gov/2007/incontinencestatement.pdf Last accessed November 2012
- Allergan Data On File
- Allergan Data On File