Click here to close now.

SYS-CON MEDIA Authors: Eva Belanyiova, tru welu, Blue Box Blog, Kevin Jackson, Peter Silva

News Feed Item

Allergan's BOTOX® (botulinum toxin type A) Receives a Positive Opinion in Fourteen European Countries for Idiopathic Overactive Bladder

MARLOW, England, December 19, 2012 /PRNewswire/ --

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

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).

About BOTOX®

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]

About Allergan

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.

Forward-Looking Statement

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.  

© Allergan Ltd. BOTOX® is a registered trademark owned by Allergan, Inc.

References:

  1. 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
  2. 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
  3. Reeves P et al. The current and future burden and cost of overactive bladder in five European countries. European Urology, 2006; 50: 1050-1057
  4. 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
  5. Pelletier EM et al. Pharmacotherapy adherence and costs versus nonpharmacologic management in overactive bladder. Am J Manag Care 2009;15:S108-14
  6. 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
  7. Tubaro A. Defining Overactive bladder: Epidemiology and burden of disease. Urology, 2004; 64 (Suppl 6A): 2-6
  8. 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
  9. Allergan Data On File
  10. Allergan Data On File

Media contacts
For further information please contact:
Janet Kettels, Allergan - [email protected] or +44(0)7738-506-476
Victoria Bramham, CCA London - [email protected] or +44(0)207-632-1896

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The web app is Agile. The REST API is Agile. The testing and planning are Agile. But alas, Data infrastructures certainly are not. Once an application matures, changing the shape or indexing scheme of data often forces at best a top down planning exercise and at worst includes schema changes which force downtime. The time has come for a new approach that fundamentally advances the agility of distributed data infrastructures. Come learn about a new solution to the problems faced by software orga...
Akana, a leading provider of API Management, API Security and Cloud Integration solutions, announced that it is introducing DevOps automation to the API lifecycle. New capabilities in Akana's API Management platform significantly reduce the time required to update API definitions and versions. DevOps teams will be able to work faster in designing and developing APIs, as well as managing them at runtime and publishing them to a portal.
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
2015 predictions circa 1970: houses anticipate our needs and adapt, city infrastructure is citizen and situation aware, office buildings identify and preprocess you. Today smart buildings have no such collective conscience, no shared set of fundamental services to identify, predict and synchronize around us. LiveSpace and M2Mi are changing that. LiveSpace Smart Environment devices deliver over the M2Mi IoT Platform real time presence, awareness and intent analytics as a service to local connecte...
DevOps Summit at Cloud Expo New York is offering a limited time FREE "Expo Plus" registration option in New York. On site registration price of $1,95 will be set to 'free' for delegates who register during special offer. To take advantage of this opportunity, attendees can use the coupon code, and secure their registration to attend all keynotes, @DevOpsSummit sessions at Cloud Expo, expo floor, and SYS-CON.tv power panels. Special FREE registration givess access to all Containers and Microservi...
The only place to be Nov 3-5 is Cloud Expo | @ThingsExpo | DevOps Summit 2015 West at the Santa Clara Convention Center in Santa Clara, CA. Join us there as delegates from all over the world come to listen to and engage with speakers & sponsors from the leading Cloud Computing, IoT, Big Data and DevOps companies. Cloud Expo & @ThingsExpo are the leading events covering the booming market of Cloud Computing, IoT & Big Data for the enterprise. Speakers from all over the world will be hand-picked...
The world is at a tipping point where the technology, the device and global adoption are converging to such a point that we will see an explosion of a world where smartphone devices not only allow us to talk to each other, but allow for communication between everything – serving as a central hub from which we control our world – MediaTek is at the heart of both driving this and allowing the markets to drive this reality forward themselves. The next wave of consumer gadgets is here – smart, con...
The basic integration architecture, as defined by ESBs, hasn’t changed for more than a decade. Most cloud integration providers still rely on an ESB architecture and their proprietary connectors. As a result, enterprise integration projects suffer from constraints of availability and reliability of these connectors that are not re-usable across other integration vendors. However, the rapid adoption of APIs and almost ubiquitous availability of APIs amongst most SaaS and Cloud applications are ra...
The enterprise market will drive IoT device adoption over the next five years. In his session at @ThingsExpo, John Greenough, an analyst at BI Intelligence, division of Business Insider, will analyze how companies will adopt IoT products and the associated cost of adopting those products. John Greenough is the lead analyst covering the Internet of Things for BI Intelligence- Business Insider’s paid research service. Numerous IoT companies have cited his analysis of the IoT. Prior to joining B...
While there are hundreds of public and private cloud hosting providers to choose from, not all clouds are created equal. If you’re seeking to host enterprise-level mission-critical applications, where Cloud Security is a primary concern, WHOA.com is setting new standards for cloud hosting, and has established itself as a major contender in the marketplace. We are constantly seeking ways to innovate and leverage state-of-the-art technologies. In his session at 16th Cloud Expo, Mike Rivera, Seni...
“We are a managed services company. We have taken the key aspects of the cloud and the purposed data center and merged the two together and launched the Purposed Cloud about 18–24 months ago," explained Chetan Patwardhan, CEO of Stratogent, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that the "First Containers & Microservices Conference" will take place June 9-11, 2015, at the Javits Center in New York City. The “Second Containers & Microservices Conference” will take place November 3-5, 2015, at Santa Clara Convention Center, Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
SYS-CON Events announced today DevOps.com will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Launched in 2014, DevOps.com has quickly established itself as an indispensable resource for DevOps education and community building. DevOps.com make it their mission to cover all aspects of DevOps – philosophy, tools, business impact, best practices and more.
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it!