A total of 1384 patients were evaluated for 24 weeks during the clinical trials.
In the first trial, Botox reduced the headache days by 7.8 days in comparison to 6.4 days drop among patients administered a placebo, a medical intervention in which a patient is given an inert sugar pill and told that it may improve his/her condition.
In the second trial, a 9 days reduction was observed among Botox-treated patents as compared to 6.7 days decline among the placebo-treated patients.
The first trial proved to be a failure as it could not trim down the number of migraine episodes compared with a placebo. However, the second trial went successful. And Allergen Inc. maintains that Food and Drug Administration of U.S. (FDA) is most interested in the results of the second trial.
The data "are solid and should lead to FDA approval" of Botox as a treatment for people with frequent migraines, according to William Blair's (Chicago based investment firm) Ben Andrew.
The results of the trials would be presented for the first time at a meeting of the International Headache Society in Philadelphia where it would be decided whether the drug is effective or not.
Botox good for wrinkles as well as migraine
The drug may prove to be a useful for people who suffer from chronic migraine problems at least 15 days in a month and do not get relief from other treatments. Botox is expected to prevent the occurrence of migraine, but it may not stop the headaches altogether.
Apart from treating facial wrinkles, Botox that is a neurotoxin (toxin that act specifically on nerve cells) is also used to treat other ailments including uncontrollable blinking, crossed eyes, uncontrollable contractions of neck and shoulder muscles and excessive underarm sweating.
According to the American Medical Association (AMA), migraines are extreme headaches that can cause nausea, vomiting and sensitivity to light. Any kind of anxiety, stress, exposure to light, caffeine, alcohol, hunger, or sleeplessness can prompt this type of severe headache.
Allergen’s stock surges
The trial results were released last September. Since then, Allergan’s stock price has received a soaring raise from 94 cents or 1.1 percent to $56.80 in the New York Stock Exchange.
Analysts maintain that should the FDA grant approval, the drug has the potential to contribute $1 billion in added sales annually.
It is reported that Allergan Inc. will file for U.S. regulatory approval of Botox for treatment of chronic migraine by the end of this quarter.
Executives from the company informed that the findings of the trials have been submitted to a medical journal, and it is also expected that the data of the trials will be supplied to the U.S. regulators before Sept. 30.
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