Botox approved as a migraine remedy

Botox approved as a migraine medicine in the US by the FDA
The popular anti-wrinkle agent Botox is enriched with an application method. In the US, the FDA has approved the nerve agent Botox, currently used primarily for wrinkle smoothing, for the preventive treatment of chronic migraine.

Preventive effect of Botox in migraine
About 3.2 million people suffer according to the pharmaceutical manufacturer „Allergan“ chronic migraine in the US, which occurs on average 15 days a month for one to four hours. With the approval of Botox for the preventive treatment of chronic headache episodes, there is once more hope for an efficient treatment for those affected. Because the two PREEMPT studies (Phase III Research Evaluating Migraine Prophylaxis Therapy), which underlie the approval, come to the conclusion that the headache days through the injection of Botox on average by more than 50 percent go back. In the study, 1,384 adults with chronic migraine were treated with either Botox or a placebo preparation, each receiving 31 to 39 injections every 12 weeks in seven muscles of the head and neck. On average, the number of monthly headache days due to treatment with Botox dropped by 8.8 days. It is noticeable, however, that also in the patients treated with placebo injections, the headache decreased by 6.6 days or 44 percent. A remarkable placebo effect, which shows that Botox increases the success of treatment by just under 15 percent.

In addition, one percent of Botox-treated subjects in the first week deteriorated to such a degree that they needed hospitalization. The PREEMPT studies also included numerous side effects such as head and neck pain, facial paralysis, drooping eyelids, bronchitis and muscle weakness, pain and spasm. However, the side effects reported by 62.4% of participants after Botox and 51.7% after placebo injections were mild to moderate in the study as a whole. The number of dropouts was also negligible at 3.8 percent.

Constantly new fields of application for Botox
Despite the widespread skepticism among doctors, the American health authority FDA is to the joy of the manufacturer „Allergan“ now followed the example of the British authorities and has been approved as a second country Botox for use in chronic migraine patients. A corresponding application for admission is also planned for Germany. For the first time, the active ingredient developed on the basis of the bacterial toxin botulinum toxin A was approved in the USA in 1989 for the treatment of eyelid cramps and certain forms of strabismus. The medicine took advantage of the muscle-relaxing effect of the neurotoxin. From 2002, the same effect was approved for cosmetic treatments to smooth wrinkles between the eyebrows. Over the years, numerous other treatment fields were added. Botox is now approved for 20 different indications and is used in 80 countries worldwide.

In Germany, for example, the use of Botox against wrinkles since 2006 is allowed. According to estimates by the German Society for Neurology, more than one million people in Germany meet the inclusion criteria for the new treatment method for migraine prophylaxis. Altogether, around eight million people in Germany suffer from migraine, according to the information provided by the German Migraine and Headache Society. However, Botox treatment is limited to chronic migraine patients only because, according to the FDA, Botox does not work in patients who are less likely to suffer from migraine.

Strongest natural neurotoxin
However, it is not without reason that the manufacturer's technical information contains warnings in which physicians and patients are made aware that the active substance is the strongest known natural neurotoxin. This can migrate after the injection in the body, so that generally life-threatening difficulties in swallowing and breathing are possible, so the information of the pharmaceutical manufacturer. However, this has not stopped the treatment of the growing number of those who lack beauty. Chronic migraine sufferers are even more likely to be more positive about such therapy, as they usually cling to any straw that offers the prospect of a few more painless days. (fp, 20.10.2010)

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