FDA approves Allergan’s Botox for chronic migraine treatment

Migraine is characterized by an intense pulsing or throbbing pain in one area of the head, which could persist for 15 days or more in month or more than four hours a day in chronic stage.  Migraine could accompany nausea, vomiting and sensitivity to light and sound. It is estimated that around 3.2 million Americans suffer from chronic migraine. The World Health Organization ranks migraine as the 19th most disabling disease. There are no good treatments for migraine.  Botox injections, manufactured by Allergan, have shown promise in prevention of chronic migraine and got FDA approval.  

How does migraine affect?
Migraine is accompanied by severe headache and it referred to as the most disabling form of headache.  Dr. Russell Katz, of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said that “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.” 

What is Botox?
Botox is a drug with generic name onabotulinumtoxinA.  Botox is manufactured by Allergan, which has been approved for 21 different indication in some 80 countries, including treatment of the abnormal head position and neck pain associated with cervical dystonia in adults, symptoms of severe underarm sweating and treatment of increased muscle stiffness in elbow, wrist and finger muscles in adults with upper-limb spasticity. 

Why FDA approved Botox for chronic migraine?
Allergan funded two studies that were submitted to the FDA.  The study was conducted on 1,384 adults from 122 study sites in Europe and North America. The results of the study indicate that

  • Patients that were given Botox experienced 7.8 and 9.2 fewer days of migraine than they had before the studies started, after duration of six months.
  • Patients who were given placebo (sugar pill) experienced 6.4 and 6.9 fewer headache days.
  • Over the 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. 

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Is Botox taken as oral medicine for chronic migraine relief?

The FDA recommended Botox be injected approximately every three months around the head and neck to dull future headache symptoms. 

In what cases Botox in not indicated for migraine?
It was reported that Botox has not been shown to work against migraines that occur 14 days or fewer per month.  Also, Botox did not show effectiveness for other forms of headache. 

Are there side effects of Botox?
There were some side effects reported for Botox that were observed during the studies:

  • Migraines became worse in about 1% of patients on Botox (versus 0.3% on placebo).  Conditions worsened to the level that they were hospitalized, but it was generally well-tolerated.
  • Less than 2% 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.” 

Although it may seem like that Botox did not provide huge benefits to the patients suffering from chronic migraine.  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 said that “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.”

Source: CNN

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