Health Canada approves BOTOX® as prophylactic treatment for chronic migraine

Clinical studies show close to 70 per cent of patients experienced more than 50 per cent reduction in migraine days after one year of treatment

MARKHAM, ON, Nov. 14, 2011 /PRNewswire/ - Chronic Migraine sufferers in Canada now have an option to prevent the onset of headaches that occur over 15 days a month and leave patients debilitated.  Health Canada has approved BOTOX® (onabotulinumtoxinA) manufactured by Allergan, Inc. as a prophylactic (preventive) treatment for headaches in adult patients with Chronic Migraine who suffer from headaches 15 days or more per month, lasting four hours a day or longer.¹

"This is an important clinical advancement benefiting patients in Canada who suffer from Chronic Migraine," says Stu Fowler, President & General Manager, Allergan Canada. "Until now, patients have had to rely on temporary, short-term means of coping with chronic headache pain.  The approval of BOTOX® as a preventive treatment for Chronic Migraine now offers neurologists, as well as headache and pain specialists a new, clinically-proven way to manage this debilitating condition."

Based on global estimates, over 270,000* Canadians who are 18 years of age and older are Chronic Migraine sufferers, costing the Canadian economy roughly $1,800** per patient, per year in healthcare spending towards healthcare provider visits, emergency department visits, diagnostic testing and headache-specific medications.^2,3

"Chronic Migraine is vastly under recognized and under-diagnosed in Canada, as it is around the world," says neurologist Dr. Jonathan Gladstone, FRCPC, Vice President of the Canadian Headache Society and Director of the Gladstone Headache Clinic in Toronto, Ontario.  "The reality is that patients with chronic headaches frequently receive their care primarily from allied-health professionals and are often unaware of the available treatment options to mitigate their migraines. Many migraineurs bounce around the healthcare system without an appropriate diagnosis and/or treatment plan and unfortunately, as a result, they often end up missing work, school, family, recreational and social functions."

In addition to direct healthcare costs, lost productivity and lost work days (absenteeism) account for major sources of indirect costs associated with migraine.⁴  In a self-reported study of the impact of migraine on work, 28 per cent of migraine sufferers reported working fewer hours as a result of their headaches, 24 per cent chose less demanding work because of their headaches, and 8 per cent actually changed their employment as a result of their headaches.⁵  In Canada, the cost of migraine in the workplace is approximately $500 million annually.⁴

"Chronic Migraine causes great disability in people who are affected by this condition, and can reduce a patient's quality of life in proportions that the average person can't even fathom," says Valerie South, Executive Director, Headache Network Canada. "Access to new treatment options, like BOTOX®, that fill the current gap in care is critical to these patients, who suffer with pain for at least half their lives."

When treating Chronic Migraine, qualified medical specialists administer BOTOX® injections across seven specific head and neck muscle areas for a total of 155-195U per treatment session.¹  When injected at labeled doses and in the recommended locations, BOTOX® is expected to produce results lasting up to three months (12 weeks) depending on the individual patient.¹

Patients should seek advice from a neurologist, headache or pain specialist who is qualified to evaluate, diagnose and properly manage this condition for more information about treatment options that may be right for them.

ABOUT THE DATA
Health Canada's approval of BOTOX® is based on data collected in Allergan's PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) program, which was designed to evaluate the safety and efficacy of BOTOX® as a preventive treatment of headaches in adults with Chronic Migraine. PREEMPT is the largest clinical program in Chronic Migraine, consisting of two double-blind, placebo-controlled clinical trials involving 1,384 adults from 122 study sites in North America and Europe.^6,7

In both PREEMPT studies, patients treated with BOTOX® experienced a significantly greater decrease in the frequency of headache days from baseline compared to patients treated with placebo at week 24 (7.8 and 9.2 fewer days for the BOTOX® group, versus 6.4 and 6.9 days for the placebo group, respectively).  Also at week 24, patients treated with BOTOX® experienced a total cumulative reduction in headache hours by 107 and 134 hours, respectively, compared to 70 and 95 hours, respectively, in patients treated with placebo.²  Patients treated with BOTOX® also had a significantly greater mean decrease from baseline in the frequency of headache days at most time points from week four to week 24 in the first study, and all time points from week four to week 24 in the second study, compared to patients treated with placebo.^6,7

In general, BOTOX® treatment was well tolerated by the large majority of patients and the discontinuation rate due to adverse events was low in both treatment arms (3.8 per cent in the BOTOX® treated group and 1.2 per cent in the placebo group).²  Adverse reactions reported by greater than two per cent of patients treated with BOTOX® and more frequent than in patients treated with placebo included eyelid ptosis (eyelid drooping), injection site pain, sinusitis, bronchitis, neck pain, musculoskeletal stiffness, muscular weakness, myalgia (muscle pain), musculoskeletal pain, headache, migraine and facial paresis.²  The most frequently reported adverse events leading to discontinuation in the BOTOX® group were neck pain, muscular weakness, headache, and migraine.¹

Severe worsening of migraine requiring hospitalization occurred in approximately one per cent of patients treated with BOTOX® in both studies, usually within the first week after treatment, compared to 0.3 per cent of patients treated with placebo.^6,7

ABOUT CHRONIC MIGRAINE
Chronic Migraine is a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 days or more per month for at least three months, with at least eight headache days per month being migraine.³  Unlike patients who suffer from "episodic" migraines (i.e., migraines that are infrequent and/or vary in duration), patients with Chronic Migraine have increased rates of medical and psychiatric co-morbidities, and are approximately twice as likely to have depression, anxiety and chronic pain conditions.³

It is estimated that approximately 80 per cent of those who meet the definition of Chronic Migraine have not received an accurate diagnosis⁸ and, as a result, may be unaware of their treatment options.  This may be due to mischaracterization of Chronic Migraine as a less severe headache disorder.

The World Health Organization (WHO) ranks migraine as one of the top 20 most disabling diseases and notes that a day lived with severe migraine can be more disabling than blindness, paraplegia, angina (after walking 50 meters) or rheumatoid arthritis.^9,10

Although Chronic Migraine occurs in both men and women, women are three times more likely than men to suffer from migraines.  Chronic Migraine can also be influenced by life stress, sleep habits, diet and overuse of acute medications that relieve pain associated with symptoms of headache.¹¹

For more information about Chronic Migraine, its symptoms and triggers visit: www.MyChronicMigraine.ca.

ABOUT BOTOX®
BOTOX® is a prescription-only medical product that contains tiny amounts of a highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum.  BOTOX® was first approved for use in Canada 21 years ago for the treatment of strabismus (crossed eyes) and blepharospasm (uncontrollable blinking), making it the first botulinum toxin type A product approved in the world.  Since then, BOTOX® has been recognized by regulatory authorities worldwide as an effective treatment for 21 different indications in approximately 80 countries, benefiting millions of patients worldwide.

In Canada, BOTOX® is also approved for the treatment of dynamic equinus foot deformity due to spasticity in pediatric cerebral palsy in patients two years of age or older; to reduce the subjective symptoms and objective signs of cervical dystonia (muscle contractions in the neck); for the treatment of hyperhidrosis of the axilla (excessive underarm sweating); for the management of focal spasticity (muscle tightness that can affect multiple areas of the body) and now for the prophylactic (preventive) treatment for headaches in adult patients with Chronic Migraine who suffer from headaches 15 days or more per month, lasting four hours a day or longer.¹

In addition to its therapeutic uses, the same formulation of BOTOX® with dosing specific to moderate to severe glabellar lines (frown lines between the eyebrows) has been available in Canada under the trade name BOTOX Cosmetic® since 2001.  BOTOX Cosmetic® is also indicated for the treatment of upper facial rhytids (forehead wrinkles) and lateral canthus (crow's feet).¹²

The safety and efficacy of BOTOX® have been well-established in approximately 50 randomized, placebo-controlled clinical trials and in approximately 11,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan's clinical trials.  Worldwide, approximately 26 million vials of BOTOX® and BOTOX Cosmetic® have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1989-2009).  With approximately 2,300 articles on BOTOX® and BOTOX Cosmetic® in scientific and medical journals, BOTOX® is one of the most widely researched medicines in the world.

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 10,000 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, obesity intervention and urologics, Allergan is proud to celebrate 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.  In Canada, Allergan employs close to 200 people and has a corporate head office in Markham, Ontario.

Additional Link:
www.MyChronicMigraine.ca

REFERENCES:
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1. BOTOX® Canadian Product Monograph.  Updated October 2011.
2. Statistics Canada. Table 051-0001 - Estimates of Population, by Age Group and Sex for July 1, Canada, Provinces and Territories, Annual (Persons Unless Otherwise Noted), CANSIM (database). Available at http://www5.statcan.gc.ca/cansim/a01?lang=eng. Last accessed August 16, 2011.
3. Stokes M, et al. Cost of Health Care among Patients with Chronic Migraine and Episodic Migraine in Canada and the USA: Results from the International Burden of Migraine Study (IBMS). Headache. 2011 July;51(7):1058-1077.
4. Shelagh R. The Astronomical Costs of Migraine. Help for Headaches: A Canadian Registered Headache Charity (Ontario).  Available at http://www.headache-help.org/astronomical-costs-of-migraine. Last accessed August 16, 2011.
5. Lucas S. Chapter 1: Epidemiology of Primary Headache in Women. Decker Publishing. Available at http://www.bcdecker.com/SampleOfChapter/1550091808.pdf.  Last accessed August 16, 2011.
6. Deiner HC, et al.  OnabotulinumtoxinA For Treatment Of Chronic Migraine: Results From The Double-Blind, Randomized, Placebo-Controlled Phase Of The PREEMPT 2 Trial.  Cephalalgia.  2010;0(00):1-11. Available at http://cep.sagepub.com/content/30/7.toc.  Last accessed September 8, 2010.
7. Aurora SK, et al.  OnabotulinumtoxinA For Treatment Of Chronic Migraine: Results From The Double-Blind, Randomized, Placebo-controlled Phase Of The PREEMPT 1 Trial.  Cephalalgia.  2010;0(00):1-11. Available at http://cep.sagepub.com/content/30/7.toc.  Last accessed September 8, 2010.
8. Bigal ME, et al. Chronic Migraine in the Population. Neurology. 2008;71:559-566.
9. World Health Organization (WHO).  Fact Sheet No 277: Headache Disorders.  Available at http://www.who.int/mediacentre/factsheets/fs277/en/.  Last accessed October 20, 2011.
10. Harwood RH, et al.  Current and Future Worldwide Prevalence of Dependency, Its Relationship to Total Population, and Dependency Ratio.  Bulletin of the World Health Organization.  2004;82(4):251-258.
11. Eross EJ.  Chronic Migraine and Medication-Overuse Headache.  Neurology.  2006;66:E43-E44.
12. BOTOX Cosmetic® Canadian Product Monograph.  Updated June 2011.

SOURCE Allergan Inc.

Image with caption: "Chronic Migraine is a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 days or more per month for at least three months, with at least eight headache days being migraine.(CNW Group/Allergan Inc.)". Image available at: http://photos.newswire.ca/images/download/20111114_C5229_PHOTO_EN_6627.jpg

Image with caption: "BOTOX® (onabotulinumtoxinA) is now approved for the treatment of headaches in adult patients with Chronic Migraine in Canada. (CNW Group/Allergan Inc.)". Image available at: http://photos.newswire.ca/images/download/20111114_C5229_PHOTO_EN_6634.jpg

Video with caption: "Video: Chronic migraine patients being treated with BOTOX® (onabotulinumtoxinA) in recommended injection sites.". Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20111114_C5229_VIDEO_EN_6628.mp4&posterurl=http://photos.newswire.ca/images/20111114_C5229_PHOTO_EN_6628.jpg&clientName=Allergan%20Inc%2E&caption=Video%3A%20Chronic%20migraine%20patients%20being%20treated%20with%20BOTOX%26%23174%3B%0D%0A%28onabotulinumtoxinA%29%20in%20recommended%20injection%20sites%2E&title=Chronic%20migraine%20patients%20being%20treated%20with%20BOTOX%26%23174%3B

Image with caption: "Illustration of recommended BOTOX® (onabotulinumtoxinA) injection sites in the shoulder and head muscle areas. (CNW Group/Allergan Inc.)". Image available at: http://photos.newswire.ca/images/download/20111114_C5229_PHOTO_EN_6629.jpg

Image with caption: "Illustration of recommended BOTOX® (onabotulinumtoxinA) injection sites in head muscle areas. (CNW Group/Allergan Inc.)". Image available at: http://photos.newswire.ca/images/download/20111114_C5229_PHOTO_EN_6630.jpg

Image with caption: "Illustration of recommended BOTOX® (onabotulinumtoxinA) injection sites in the forehead muscle area. (CNW Group/Allergan Inc.)". Image available at: http://photos.newswire.ca/images/download/20111114_C5229_PHOTO_EN_6631.jpg

PDF with caption: "Product Fact Sheet ". PDF available at: http://stream1.newswire.ca/media/2011/11/14/20111114_C5229_DOC_EN_6632.pdf

PDF with caption: "Disease Backgrounder ". PDF available at: http://stream1.newswire.ca/media/2011/11/14/20111114_C5229_DOC_EN_6633.pdf