Allergan's BOTOX® (botulinum toxin type A) Receives Authorisation for the Treatment of Overactive Bladder in the UK

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Allergan

10 Sep, 2013, 23:01 GMT

MARLOW, England, September 11, 2013 /PRNewswire/ --

BOTOX® injections provide a new and long lasting approach to the management of overactive bladder

Today, Allergan Inc. announced that BOTOX® has been licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the management of bladder dysfunctions in adult patients with overactive bladder (OAB) with symptoms of urinary incontinence, urgency and frequency and who are not adequately managed with anticholinergics.[1] The use of botulinum toxin type A in the management of these patients is recommended by the National Institute for Health and Care Excellence in its guidelines on Urinary Incontinence[2]. This is the tenth indication for BOTOX® in the UK and marks another key milestone in bringing this innovative treatment to patients suffering from the symptoms of OAB. BOTOX® is the only botulinum toxin indicated for the management of bladder dysfunctions in the UK. 

"BOTOX® provides an important treatment alternative delivering both a new mode of action and targeted method of administration for the management of OAB," said Professor Christopher Chapple, Urology Department, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust and a key investigator in the overactive bladder registration trials. "With this authorisation, I can now offer my patients an effective, well tolerated treatment that may help them gain control of their bladder for up to six months. Having the ability to better control and manage bladder function can be life-changing for patients."

Overactive bladder is a common condition in the UK, with studies indicating that up to 19% of the population may have the condition.[3],[4] OAB is a disabling and socially isolating condition affecting both men and women of all ages.[3] It has a significant effect on daily activities including work life, sexual intimacy, mental health and sleep quality, thus reducing patients' quality of life.[5]Two multi-national studies report that only 16-28% of OAB patients receive oral medication to manage their condition.[6],[7] However, research also indicates that more than 50% of patients stop taking at least one oral medication within 12 months, either due to lack of efficacy or side-effects.[8],[9]

"The symptoms of OAB, such as urgency or urinary leakage, can have a considerable negative impact on emotional well-being, causing embarrassment, low self-esteem, depression and loss of independence," commented Dr Con Kelleher, Consultant Obstetrician and Gynaecologist, Guy's and St Thomas', London. "Many of these patients have struggled with the symptoms of OAB for many years and now finally there is a new treatment that could change their lives. By helping to restore control over their bladder function, BOTOX® can reduce the limitations my patients experience and help them to begin a normal life again."

When used in the treatment of OAB, BOTOX® works by helping to relax the bladder muscle which minimises sudden contraction and reduces leakage. It also targets the nerves controlling the sensation of urgency, which is one of the most bothersome symptoms of OAB.[1]  

"We are pleased that BOTOX® has received the green light from the MHRA for the treatment of overactive bladder in patients who are struggling to control their symptoms with anticholinergic medications," said Paul Navarre, President, Allergan Europe, Africa, Middle-East. "This authorisation recognises Allergan's long standing commitment to innovation in botulinum toxin research. With two licences for bladder dysfunction as well as on-going R&D investment, Allergan is emerging as a global speciality leader in urology."

This authorisation is based on the results of the EMBARK study programme; two phase III, randomised, placebo-controlled, multi-centre trials conducted in both the US and EU involving over 1,100 patients. Patients were enrolled into the trials if their symptoms were not adequately managed with anticholinergic therapy due to side effects or lack of efficacy. On average, patients were experiencing more than five urinary incontinence (leakage) episodes per day.[1]

  • In these trials, patients who received local injections of BOTOX® (100 Units) into the bladder muscle experienced a significant and clinically relevant reduction of urinary incontinence (leakage) compared to those treated with placebo.[1]
  • Three times as many patients treated with BOTOX® became dry (no urinary leakage at 12 weeks) compared to placebo (27.1% achieved complete continence with BOTOX® vs. 8.4% with placebo at week 12) after the first injection.[1]
  • Significantly greater improvements in the most common symptoms of OAB including urgency (urge to urinate) and frequency of urination also occurred with BOTOX® treatment compared to placebo.[1]
  • Patients treated with Allergan's botulinum toxin type A product also reported meaningful improvements in their quality of life compared to patients treated with placebo.[1]
  • In the clinical studies, patients treated with Allergan's botulinum toxin type A experienced improvement in symptoms as early as two weeks post-treatment with the effects lasting for approximately 24 weeks, on average.[1]

Like all medicines, Allergan's botulinum toxin type A product can cause side effects, although not everybody gets them. In general, side effects occur within the first few days following injection. They usually last only for a short time, but they may last for several months and in rare cases, longer. Overall, Allergan's botulinum toxin type A product treatment was generally well-tolerated in the majority of patients in the EMBARK phase III clinical trial programme. The most common adverse reactions were mainly associated with the urinary tract and included urinary tract infections and painful urination after injection.[1]

"Overactive bladder is currently an underdiagnosed and undertreated condition which can cause considerable distress.  We know that existing treatments are not always suitable for everyone and welcome a new treatment option that increases patient choice and offers an alternative for people who may not be able to tolerate established solutions," says Robert Dixon, Chief Executive Officer of Bladder and Bowel Foundation. "We encourage the many people who may be suffering from bladder problems, in particular from urinary leakage, to talk to their doctor about treatments and management options that may help them gain control of their bladder."

Notes to Editors

About Overactive Bladder

While the exact cause is often unknown, overactive bladder (OAB) is a medical condition where involuntary contractions of the bladder can cause an uncontrolled urge to urinate (urgency), frequent urination (frequency) frequent night-time urination (nocturia) and the 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. Worldwide, approximately 35 million vials of Allergan's botulinum toxin type A products have been distributed over the past 21 years (1990-2012). The safety and efficacy of BOTOX® has been well-established with approximately 65 randomised, 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 11,200 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, urologics and medical aesthetics, 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.

Forward-Looking Statement

This press release contains "forward-looking statements", including but not limited to the statements by Professor Christopher Chapple, Dr Con Kelleher, Mr Paul Navarre and Mr Robert Dixon and other statements regarding research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding the use of BOTOX® for the treatment of overactive bladder. 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.  Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. 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 2012 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. UK BOTOX® Summary of Product Characteristics, 2013 http://www.medicines.org.uk
  2. National Institute for Health and Clinical Evidence, Urinary Incontinence, the management of urinary incontinence in women. October 2006. http://www.nice.org.uk/nicemedia/pdf/CG40fullguideline.pdf
  3. 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
  4. 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
  5. Tubaro A. Defining Overactive bladder: Epidemiology and burden of disease. Urology, 2004; 64 (Suppl 6A): 2-6
  6. Reeves P, et al. The current and future burden and cost of overactive bladder in five European countries. European Urology, 2006; 50: 1050-1057
  7. 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
  8. Pelletier EM, et al. Pharmacotherapy adherence and costs versus nonpharmacologic management in overactive bladder. Am J Manag Care 2009;15:S108-14
  9. 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
  10. Mohindru A et al. 2013. Analysis of clinical and non-clinical, peer-reviewed, published studies investigating the use of commercially available botulinum toxins: An online literature review. Abstract. In press

Media contacts
For further information please contact:
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kettels_janet@allergan.com or +44(0)7738-506 476

Bahar Turkoglu, Allergan
turkoglu_bahar@allergan.com or +44(0)7717-736-209

Marcie Doser, Chandler Chicco Agency
m.doser@cca-uk.com or +44(0)20-7632-1839