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press release : PR Newswire
Health Canada approves BOTOX? as prophylactic treatment for chronic migraine
November 14, 2011

MARKHAM, ON, Nov. 14, 2011 /PRNewswire via COMTEX/ -- 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

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: | Get the facts about Chronic Migraine

Additional detailed information: Health Canada approves BOTOX? as prophylactic treatment for chronic migraine - MarketWatch

Migraine Insights: Migraines 'a quality of life issue' -
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