Botox, the popular wrinkle remover could help in treating chronic migraines, says the manufacturer. Irvine, California based Allergan has said clinical trials that have been conducted on Botox, the commercial name of botulinum toxin type A, have shown positive results in treating adult symptoms of chronic migraines.

Affecting millions of people in the United States and more of a neurological illness than a simple headache, the cause of a migraine still remains a mystery. Characterized by severe, repetitive headaches which can sometimes last from 4-72 hours with additional symptoms of nausea, sensitivity to light, photophobia and at times an aura preceding the onset of the headache, migraines can be debilitating. In its milder form, sufferers aren’t aware that they have a migraine while in its severest form people find it difficult to lead a normal life while they are in the grip of a migraine attack.

Allergan announced positive results on their Phase III study which was conducted to see the effect of Botox on chronic migraine sufferers. In the study patients were divided into two groups and one was given a Botox injection every 12 weeks while the other group received a placebo injection at the same interval. The primary analysis was conducted after two treatment cycles and the injections efficiency was measured by evaluating the change in the number of headache episodes and the number of days the patient suffered from a migraine during the trial period. The main goal of the Phase III trial’s top factor for evaluation was the number of headache episodes with the number of days affected by a headache being the secondary point of evaluation.

The test showed no significant changes between the Botox and the placebo group in so far as the primary goal went. The secondary goal showed success with the toxins having decreased the duration of the headache episodes the Botox group suffered as compared to the placebo group. The second part of the Phase III trials then shifted their primary objective to reducing the number of headache days while the secondary one was to reduce the number of headache episodes. The end of this phase showed that both the primary and the secondary goals had positive results from the Botox treatment as compared to the placebo group with both the number of days a headache lasted as well as the number of headache episodes both showing a decrease.

Scott Whitcup, M.D., and Allergan’s Executive V.P., in Research in Development, said, “We are pleased with the top-line results of our Phase III clinical trials which show that BOTOX ® treatment provided benefit to these patients whose lives have been profoundly impacted by this severely debilitating condition.” He added, “It is gratifying to focus our research and development efforts on an indication that addresses such an important unmet medical need.”

Although Botox is not an approved treatment to treat migraines yet, it is the first method being evaluated to treat the problem. Allergen is hopeful to file for a supplemental biological license and over the next few years it could get FDA approval. If the company gets the approval the sales of Botox could touch $ 400 million by 2012 with each vial of Botox costing about $ 530.