Relief for Migraine Sufferers Boosts Allergan’s Stock after Fed Crackdown

For migraine sufferers, the recent FDA approval of Botox as a migraine treatment gives them access to the only thing that might actually work—injections of Botox.

Migraine victims have long awaited a drug that would avoid migraines, not just treat them after they start. Studies prove Botox’s ability to block nerves that cause a migraine. In one study, chronic migraine sufferers getting Botox injections had 9 fewer days of headaches per month compared with those receiving a placebo, who reported 6.7 fewer.

In another study that was funded by Allergan, Botox users reported 7.8 fewer days per month of any headaches (including migraines) compared with 6.4 days’ fewer headaches reported by those receiving the placebo injections.

Guilty Plea

Allergan had previously been ordered by the Justice Department to pay $375 million in fines for unauthorized promotion of Botox for headaches and cerebral palsy from 2000 to 2005. The fine was lowered to $350 million upon Allergan’s willingness to plead guilty to the charges. Allergan was also ordered to forfeit $25 million in assets and to stick to a 5-year mandated plan to disclose any payments to doctors and annually certify that their various divisions meet federal health care requirements.

Who can use it?

Men and women who have a migraine headache at least 15 days a month with pain lasting at least four hours qualify for treatment. It is assumed that health insurance carriers will approve this as a covered expense, since no other treatment has provided similar results. Treatment includes multiple injections around the neck and head every 3 months.

Allergan spokesperson, Caroline Van Hove, believes that insurers are unlikely to fight coverage of the drug since “this is a population that hasn’t responded to any of the conventional treatments.” Botox was cleared for migraine treatment earlier this summer in the UK and the company anticipates approvals in the rest of Europe and Canada yet this year.

Stock Market Reaction

Allergan (AGN) is running around $72 per share this month (Oct 2010). A month ago it was averaging $66 per share. The company, which generated $1.3 billion in 2009 sales, may earn $1 billion more in annual revenue with the migraine approval, said Aaron Gal, a Sanford C. Bernstein & Co. analyst in New York, in a May 2010 report.

Botox® Efficacy Enhanced By Oral Supplements

According to recent research conducted by Charles Soparkar, M.D., Ph.D., F.A.C.S., a dietary supplement that combines zinc and phytase increases the effectiveness of Botox® Cosmetic on patients. Plastic Surgery Practice reports that the supplement, trademarked as ZYTAZE™, is patent-pending and may be available to patients as early as this month.

The study analyzed 44 patients who had taken the oral supplements prior to being injected with botulinum toxin (Botox®, Dysport®, or Myobloc®). Forty-one of the 44 patients showed noticeable results. Multiple subjects were being treated for blepharospasm, or eyelid spasms, and had previously responded poorly to the injections.

Soparkar and his team will present the findings at the American Society of Ophthalmic Plastic & Reconstructive Surgery’s 41st Annual Fall Scientific Symposium in Chicago on October 14, 2010.

"Surprisingly, the results showed that in over 90% of the patients studied, the zinc/phytase combination resulted in a remarkable improved responsiveness to treatment of blepharospasm using the same amount of botulinum toxin as previously used," Soparkar told Plastic Surgery Practice.

"The toxins seemed to have greater effect and last longer. Potentially, this could mean using less toxin, offering patients financial savings, greater safety, and more consistent results."

Perhaps future findings will prove that the natural inclusion of diets rich in phytase and zinc can also improve the results of botulinum toxin injections. Pythase can currently be found in many grains and oil seeds, while foods like oysters and wheat germ are great sources of zinc.

Don't Get Mad, Get Botox®

Getting rid of wrinkles is a reason for anyone to smile. A recent study found that Botox® could also improve someone’s mood simply by limiting his or her ability to frown.

The study, which was performed by researchers at the University of Wisconsin on 40 volunteers, tested how the patients reacted to emotional statements following an injection of Botox®. The subjects were asked to read messages that ranged from “angry” to “sad” to “happy”. Researchers then gauged the patient’s mood by observing how long it took to respond to each statement.

The subjects of the trial took slightly longer to respond to the negative statements following their treatment than they had before their Botox® injections. The elongated response time indicated that the brain had a harder time processing the negative emotion following the treatment.

"There is a long-standing idea in psychology called the facial feedback hypothesis Essentially, it says, when you're smiling, the whole world smiles with you. It's an old song, but it's right," says the study’s author, David Havas.

The facial feedback hypothesis, which dates back to Charles Darwin in the late 1800s, is the idea that one’s facial expressions can have an effect on emotional experience.

According to the research leader professor Arthur Glengerg, the brain would normally send signals to the facial muscles to frown, and in return the extent of the frown would be sent back to the brain. Under the influence of Botox®, the muscles in the face are weakened and the intensity of the emotion is in turn disrupted.

Botox® can also have the same effect on happiness as well. When injected into the lower part of the face, Botox® can obstruct a normal smile and in turn effect the brain’s ability to comprehend pleasure levels.