If you suffer migraines at least 15 days a month and have pain lasting at least four hours each time, your insurance may pay for you to have Botox injections to bring relief. The FDA has recently approved Botox as an injectable solution to migraine headaches when injected into the face and neck every three months.
You may have read that Allergan, the makers of Botox, were sued by the Feds for their previous unauthorized promotion of Botox for cerebral palsy and headaches between the years 2000 and 2005. The firm accepted the determination and paid the government $350 million plus $25 million in assets, along with an agreement for monitoring. In light of the fact that stock analysts estimate the revenue from this new approval for Botox will be in the billions, that’s a small price for Allergan to pay.
Two studies show proof that it works. In one, men and women suffering with chronic migraines reported 9 fewer migraines a month, compared with those who were given a placebo injection, who reported only 6.7 fewer migraines a month. That’s about a 30% difference. Allergan funded its own study which showed its users having 7.8 average fewer headaches per month compared with those getting the placebo, who reported only 6.4 fewer days of headaches a month.
Caroline Van Hove, Allergan spokeswoman, believes that health insurance companies will cover use of the drug because “this is a population that hasn’t responded to any of the conventional treatments.” Botox has already been approved for migraine treatment in the UK and Allergan is anticipating more approvals in the rest of Europe and Canada yet this year.
We provide this service for those of you suffering from migraines, so pick up the phone and put a stop to your chronic migraine headaches. Share the word with friends, family and co-workers and schedule time with us to treat this problem. You’ll feel so much better.
Allergan, the Orange County-based maker of Botox, has settled a case with the federal government for over $600 million. The L.A. Times reported that the settlement came about after the Justice Department pursued criminal charges against Allergan for marketing Botox for off-label use.
Allergan reportedly marketed Botox, the popular anti-wrinkle injectable, for the off-label purpose of migraine relief. While pharmaceutical firms are allowed to use their products for unapproved purposes, FDA approval is necessary in order to market the product to doctors and consumers.
It is estimated by the Justice Department that the settlement was one of the top ten largest healthcare settlements by the department.
The case came about more than two years ago following scrutiny by whistle-blower groups. Allergan promoted the popular injectable by lobbing health insurance companies to cover the off-label uses and by offering incentives to physicians who actively treated migraine patients with the drug. According to the Justice Department, Allergan spent $8 million alone on an online neurotoxin education organization to “stimulate increased use of Botox.”
Botox was also promoted to treat a plethora of medical conditions—including blepharospasm, pain and cerebral palsy—that it was not FDA approved for. While cosmetic doses, which are relatively small, carry minimal side effect, therapeutic doses can be more dangerous. Botox and competing products carry “black box” warnings that the toxin can spread from the injection site and cause life-threatening symptoms, such as trouble swallowing or breathing.
Allergan is currently awaiting FDA approval for the use of Botox on migraine sufferers. With the decision expected at the end of October, the timing of this settlement may affect the FDA’s final verdict on Botox.
To Your Health & Beauty,
Vipul R. Dev, M.D.
According to the O.C. Register’s In Your Face blog, British drug regulators have recently approved Botox® injections for the treatment of migraine headaches. This is good news for the Botox® manufacturer Allergan, who has just undergone an overhaul in their corporate lineup amidst increasing challenges from competitors.
The British approval of Botox® is a step in the right direction for widespread acceptance of the Irvine-based company to market the drug’s off-label uses. For years, Allergan has sought out FDA approval for Botox® as a migraine treatment without any luck. The company has been running clinical trials since 2004 for migraine treatment. Allergan is also seeking similar approvals in countries such as Canada, France, and Switzerland.
The British decision came in response to clinical trials performed on more than 1,300 patients. According to the O. C. Register, the study found that Botox® reduced the frequency of migraines in patients who suffered from headaches an average of 15 days or more a month. Patients who were treated with Botox® averaged 8.2 few days with migraines a month, while the placebo group experienced 6.2 few migraine days in the six months following the start of the trials.
The British study is very similar to earlier trials performed by Allergan in the U.S. Perhaps more extensive research in the United States, in conjunction with influence from the British decision, will sway the FDA to change it’s mind about the use of Botox® for migraine treatment. Just think: migraine patients may one day have Botox® covered by their health insurance while having the added benefit of wrinkle-reduction. Not too shabby, right?
To Your Health & Beauty,
Vip Dev, M.D.