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After Agreeing to Pay $600 Million Fine, Allergan Hopes BOTOX Will Soon Have a New FDA-Approved Use
by admin on: January 12th, 2012

In September 2010, Allergan, the pharmaceutical company that produces BOTOX, agreed to pay a penalty of $600 million resulting from allegations of illegally promoting BOTOX for off-label use and for contributing to false claims to Medicare and Medicaid. However, Allergan may soon make all that money back ??? and then some.

July 9, 2010, the British Medicines and Healthcare Products Regulatory Agency approved BOTOX for use in the prevention of a condition labeled ???chronic migraine.??? Chronic migraine is a debilitating condition that can cause repeated head aches lasting 4-72 hours and are sometimes accompanied by nausea, vomiting, and sensitivity to light. In the United Kingdom, it is estimated that about 700,000 people suffer from chronic migraines.

The method for using BOTOX as a treatment for chronic migraine involves a series of injections (usually around 30-40) around the shoulders, neck, and head. This therapy generally lasts about 12 weeks, after which the patient returns for injections at regular intervals. The clinical trials that were reviewed by the Medicines and Healthcare Products Regulatory Agency demonstrated that BOTOX injections, over a period of one year, produced a significant reduction in the occurrence of migraines. Out of the patients undergoing this treatment, 70 percent of the BOTOX-treated patients experienced a 50 percent reduction in the number of migraines they experienced.

Industry analysts expect that the cost of a BOTOX session for chronic migraine will cost about $1000 to $2000. If the FDA follows the example set by the British regulatory agency, the sales of BOTOX to treat chronic migraine could reach $1 billion annually through worldwide sales by the year 2016.

It should be noted that this form of therapy is not a cure, only a preventative measure. However, for people with chronic migraine, who may spend as much as half their life in pain, the reward may certainly be deemed worth the cost.

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