FDA approves Botox as migraine preventive By Tom Watkins, CNN

(CNN) -- Federal health authorities on Friday approved Botox injections for the prevention of chronic migraines in adults, an advance experts described as "modest."




In a statement, the Food and Drug Administration recommended Botox be injected approximately every three months around the head and neck to dull future headache symptoms.



The drug -- whose generic name is onabotulinumtoxinA -- has not been shown to work against migraines that occur 14 days or fewer per month, nor has it been shown to work for other forms of headache, said the statement.



Experiencing a migraine on most days "is one of the most disabling forms of headache," said Dr. Russell Katz, of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available."



Migraines, an intense pulsing or throbbing pain in one area of the head, are often accompanied by nausea, vomiting and sensitivity to light and sound, doctors say. Chronic migraines are defined as those that occur on 15 days or more for more than four hours per day.



The drug, made by Allergan, Inc., of Irvine, California, was approved last month in Britain for the same purpose.



The two company-funded studies submitted to the FDA involved 1,384 adults from 122 study sites in Europe and North America. They found that after six months, patients who got the drug experienced 7.8 and 9.2 fewer days of migraine than they had before the studies started. Those who got injections of placebo (sugar pill) experienced 6.4 and 6.9 fewer headache days.



Over those six months, patients on the drug experienced 107 and 134 fewer hours of headache, versus a reduction of 70 and 95 hours for those on placebo, according to the studies.



"The benefits are modest when you look at the overall results," said Dr. Elizabeth W. Loder, associate professor of neurology at Harvard Medical School and the chief of the division of headaches in the Department of Neurology at the Brigham and Women's Hospital in Boston. Loder was involved in an Allergan-funded trial several years ago but has no current relationship with the company.



"But, of course, within those results, there are always patients who do much better than the average and there are patients who don't have any benefit," she said.



Still, she added, "It will provide more options for patients who currently have very few forms of treatment available to them ... when you are dealing with a problem like this, even modest improvement can mean the difference between being able to go to work and not being able to function very well."



Dr. Joel Saper, director of the Michigan Head Pain and Neurological Institute and clinical professor of neurology at Michigan State University, said he has been using the drug for that purpose for more than a decade, even though it was not approved for it.



The FDA's approval will likely mean that insurance companies will pick up the tab for it now, he said. Saper, who has also participated in Allergan-funded trials, predicted "certain subsets of people will get dramatic results."



The most common adverse reactions reported by chronic migraine patients being treated with Botox were neck pain and headache, the FDA said.



About 1 percent of patients on the drug (versus 0.3 percent of those on placebo) found that their migraines worsened so much they had to be hospitalized, but it was generally well-tolerated, the company said.



In each study, less than 2 percent of patients dropped out of the study due to an adverse event.



The drug labeling warns that the effects of the botulinum toxin may spread beyond where it is injected, causing symptoms that may include life-threatening difficulties swallowing and breathing.



Botox is sold to doctors in 200-unit vials that cost $1,050, said Cyrstal Muilenburg, spokeswoman for Allergan. Last year, the drug had sales of $1.3 billion, she said.



Doctors gave administered a total of 155 units to each migraine patient in 31 injections into muscles of the head and neck, she said. The treatment was repeated at three-month intervals.



Some 3.2 million Americans are estimated to suffer from chronic migraine, though some 80 percent of them have never been diagnosed as having the disease, the company said.



The World Health Organization ranks migraine as the 19th most disabling disease. Women are three times as likely as men to suffer from migraines, which are also linked to depression and anxiety.



The drug is the same chemical entity that was approved 21 years ago for the treatment of strabismus and blepharospasm, two eye-muscle disorders.



Since then, regulators in some 80 countries have approved it for 21 different indications, including treatment of the abnormal head position and neck pain associated with cervical dystonia in adults, symptoms of severe underarm sweatingand treatment of increased muscle stiffness in elbow, wrist and finger muscles in adults with upper-limb spasticity.



Last month, Allergan settled a Justice Department investigation into its marketing practices related to uses of Botox by paying $375 million and pleading guilty to a misdemeanor misbranding charge.



The company also agreed to pay $225 million to resolve civil claims the department was asserting under the civil False Claims Act.



http://edition.cnn.com/2010/HEALTH/10/15/migraines.botox/index.html?npt=NP1%EF%BB%BF
 
dull future headache symptoms
 
dull /dʌl/ DJ /dʌl/ KK


adjective

Irregular: duller; dullest

1.not interesting or exciting 枯燥無味的；無聊的；令人生厭的

Life in a small town could be deadly dull. 小城鎮的生活可能會非常沒意思。

The countryside was flat, dull and uninteresting. 農村地區缺乏生氣，無聊乏味。

The first half of the game was pretty dull. 上半場比賽打得十分沉悶。

There's never a dull moment when John's around. 只要約翰在就不會有沉悶的時候。

2.not bright or shiny 不明亮的；不鮮明的；無光澤的

a dull colour/glow 暗淡的色彩；昏暗的光

dull, lifeless hair 無光澤、無彈性的頭髮

Her eyes were dull with dark shadows beneath them. 她目光呆滯，眼下有深深的黑眼圈。

3.not clear or loud 不清晰的；隱約的；低沉的

The gates shut behind him with a dull thud. 他走出後門砰的一聲悶響關上了。

4.not bright, with a lot of clouds 陰沉的；昏暗的；多雲的

It was a dull, grey day. 那是一個陰沉昏暗的日子。

5.not very severe, but continuous 隱隱約約的

a dull ache/pain 隱隱的疼痛

6.slow in understanding 遲鈍的；愚笨的

See also: stupid Synonym

a dull pupil/class/mind 反應遲鈍的學生／班級／頭腦

7.not busy; slow 蕭條的；不景氣的；呆滯的 especially American English

Don't sell into a dull market. 不要到蕭條的市場去推銷。

Derivative: dullness noun, uncountable

Derivative: dully adverb /ˈdʌlli/ DJ /'dʌllɪ/ KK

‘I suppose so,’ she said dully. “我看是這樣。”她木然說道。

His leg ached dully. 他的腿隱隱作痛。

Idiom: (as) dull as ditchwater British English

1.extremely boring 索然無味；無聊透頂

Variant: (as) dull as dishwater American English

verb

1.of pain or an emotion 疼痛或感情 to become or be made weaker or less severe 減輕；（使）變麻木

The tablets they gave him dulled the pain for a while. 他們給他的藥片暫時緩解了疼痛。 VN

2.to make a person slower or less lively 使遲鈍；使不活潑 VN written

He felt dulled and stupid with sleep. 他睡得迷迷糊糊，昏頭昏腦。

3.to become or to make something less bright, clean or sharp （使）變得無光澤，變模糊，變低沉