BOTOX® (Botulinum Toxin Type A) Receives a Positive Opinion in Fourteen European Countries for the Treatment of Focal Spasticity of the Ankle in Adult Post Stroke Patients

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Allergan

01 May, 2014, 09:32 GMT

MARLOW, England, May 1, 2014 /PRNewswire/ --

This Positive Opinion Paves the Way for a Second Indication for BOTOX® in Adult Spasticity Associated with Stroke  

Today, Allergan Inc. announced that BOTOX® has received a positive opinion from the Irish Medicines Board serving as reference member state in the mutual recognition procedure (MRP) for the treatment of focal spasticity of the ankle in adult post stroke patients.[1] This is an important step towards securing national licences in the 14 European countries involved in the MRP and marks a key milestone in bringing this treatment to stroke survivors across Europe who are suffering from lower limb spasticity. Spasticity is one of the most common consequences of stroke and may potentially lead to a significant loss of independence, affecting both the physical and emotional well-being of patients. These expected Marketing Authorisations will allow healthcare professionals to offer an important treatment option that could provide a real advance for patients suffering from disabling lower limb spasticity.

"We are pleased that BOTOX® has received the green light for the treatment of lower limb spasticity associated with stroke in adults," said Paul Navarre, President of Allergan EAME. "This decision underscores Allergan's long standing commitment to innovation in botulinum toxin science and our significant R&D investments. We remain committed to supporting doctors and their patients to better manage this potentially debilitating condition."

Stroke is a major public health issue in Europe with approximately 1.1 million events per year.[2] However, approximately half of all surviving stroke patients will need assistance with everyday tasks such as walking, bathing, dressing and eating.[2] Studies have shown that the prevalence of spasticity does not differ between the upper and the lower limbs, frequently affecting the wrist (66%) and the ankle (66%).[3] Moreover, 63% of stroke survivors with spasticity experience this in both the upper and lower limbs.[4] Treatment of spasticity associated with stroke requires a multidisciplinary approach and usually includes physical therapy, pharmacological treatments, and, in some cases, surgery.

This positive opinion is based on a phase III, multi-centre, randomised, double-blind, placebo-controlled study, assessing the efficacy and safety of BOTOX® in patients with post-stroke lower limb spasticity affecting the ankle. A total of 120 patients were randomised to a single treatment of Allergan's Botulinum toxin type A (300 Units) or placebo.[1] Results from the study showed:

  • Patients treated with Botulinum toxin type A achieved a significant improvement in muscle tone compared to those treated with placebo, using the Modified Ashworth Scale (MAS) ankle score and measuring baseline to week 12 results[1]
  • Significant improvements compared to placebo were also observed at the individual post-treatment visits at weeks 4, 6 and 8. The proportion of responders (patients with at least a 1 grade improvement) was also significantly higher than in placebo treated patients at these visits: Respectively 67.9%, 68.4% and 66.7%[1]
  • Botulinum toxin type A treatment was associated with a significant improvement in the investigator's clinical global impression (CGI) of functional disability compared to placebo at weeks 4, 6 and 8[1]    
  • A consistent response was observed with re-treatment[1]

Treatment with BOTOX® was generally well tolerated although it should only be used for the treatment of post-stroke lower limb spasticity following evaluation by health care professionals experienced in the management of the rehabilitation of post-stroke patients.[1]

"This Positive Opinion follows the recent approval for a similar indication in the UK, and is a very important advance for people with post-stroke spasticity. Clinicians will certainly welcome it as an important step towards better care for their patients and it will hopefully bring additional recognition to this complex and disabling condition," said Professor Anthony Ward of the North Staffordshire Rehabilitation Centre in the UK. "Studies show that BOTOX® treatment can significantly improve the muscle tone in stroke survivors with lower limb spasticity. I am pleased that my colleagues in many European countries will soon be able to offer this treatment which can bring important benefits in respect of mobility and other physical functioning to patients, even those who have been suffering from this condition for many years."

Notes to Editors 

About Stroke 

A stroke happens when the blood supply to part of the brain is cut off and brain cells are damaged or die. Strokes affect people in different ways, depending on the part of the brain that is affected, how widespread the damage is and how healthy the person was before the stroke. Strokes can permanently damage bodily functions and thought processes. Stroke is the second largest cause of death in the world, after heart disease.[5]

About Spasticity 

Spasticity is a neurological condition characterized by an abnormal increase, or hyperactivity, in muscle tone. The condition causes affected muscles to continuously contract (stay flexed, or shortened) for long periods of time. They remain stiff and tight, and resist the normal stretching that should occur during use.[6] Symptoms of spasticity can vary from mild stiffness to severe, uncontrollable muscle spasms that can be very painful, especially if joints are pulled into abnormal positions or otherwise prevent normal range of motion. Symptoms may include hypertonicity (increased muscle tone), clonus (a series of rapid muscle contractions), exaggerated deep tendon reflexes, muscle spasms, scissoring (involuntary crossing of the legs), and fixed joints. The condition can interfere with the ability to perform a range of daily activities.[6] Left untreated, affected muscles are subject to "contracture," a condition that leaves the muscles and tendons permanently shortened and can result in a permanent, and often painful, abnormal posture.[7]

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 30 million vials of Allergan's botulinum toxin type A products have been distributed for more than 20 years (1990-2012).[8] The safety and efficacy of BOTOX® has been well-established with approximately 65 randomized, placebo-controlled clinical trials involving approximately 10,000 patients[9] and, with more than 2,500 articles in scientific and medical journals, Allergan's botulinum toxin type A is one of the most widely researched toxin in the world.[10]

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 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 11,400 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 Anthony Ward, Mr Paul Navarre 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 lower limb spasticity. 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 2013 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. Allergan Data on File - Draft SmPC for BOTOX® 100 Units.
  2. Truelse T. et al. Stroke incidence and prevalence in Europe: a review of available data. European Journal of Neurology 2006,13:581-5
  3. Thibaut  A. et al. Spasticity after stroke: Physiology, assessment and treatment. Brain Inj, Early Online: 1-13
  4. Urban P. et al. Occurence and Clinical Predictors of Spasticity After Ischemic Stroke. Stroke. 2010;41:2016-2020
  5. World Health Organisation Fact sheet available at http://www.who.int/mediacentre/factsheets/fs310/en/ Last accessed April 2014
  6. NINDS Spasticity Information Page. National Institute of Neurological Disorders and Stroke. Available at http://www.ninds.nih.gov/disorders/spasticity/spasticity.htm. Last accessed on April 2014
  7. Spasticity. American Stroke Association. Available at http://www.strokeassociation.org/STROKEORG/LifeAfterStroke/RegainingIndependence/PhysicalChallenges/Spasticity_UCM_309770_Article.jsp  Last accessed on April 2014.
  8. Allergan Data on File
  9. Allergan Data on File 019
  10. Mohindru A. et al. Analysis of clinical and non-clinical, per-reviewed published studies investigating the use of commercially  available botulinum toxins: An online and offline literature review. Second International Congress on Treatment of Dystonia, 9-12 May, 2013. Hannover, Germany. Poster PO33.

UK/0526/2014
Date of Preparation: April 2014