Allergan Korea said that it has demonstrated that Botox, its botulinum toxin product, has long-term effectiveness in preventing chronic migraine headaches, through two clinical studies – COMPEL and REPOSE.
|Allergan's botulinum toxin Botox|
COMPEL was a study to evaluate the long-term safety and efficacy of Botox as a chronic migraine preventive treatment. In the COMPEL study, the company injected Botox for more than two years over a 12-week interval in 716 patients with chronic migraine headaches, who had an average of 22 headache days per month.
The results showed that the average daily number of migraine headaches decreased by 10.7 days, headache impact test-6 index fell 7.1 points, depressive symptoms dropped 78 percent, anxiety disorder improved 81.5 percent, Pittsburgh Sleep Quality Index improved from 13.3 to 11 points, and Fatigue Severity Scale improved from 38 to 30.1 points.
Botox also showed significant improvement as a chronic migraine preventive drug used in the actual medical field through REPOSE study, participated in by 633 chronic migraine patients with an average of 20.6 headache days per month.
The company administered its product for more than a year and a half (total 84 weeks) at 12-week intervals. As a result, the restrictive score for the Migraine-Specific Quality of Life Questionnaire (MSQ) index, which measures the quality of life, improved from 17.3 to 33.6 points.
The company is also preparing to publish a study comparing the efficacy and safety of Topiramate and Botox strains, used as oral prophylaxis drugs for chronic migraine headaches this year.
“The results confirm the clinical utility of Botox injection therapy in reducing headaches in patients with chronic migraine by more than 50 percent without significant side effects,” Allergan Korea CEO Kim Ji-hyun said. “Notably, the prophylactic effect was maintained despite the long-term treatment, and the safety of long-term use was confirmed, making it clear once again that it is a treatment option to be considered for the healthy life of chronic migraine patients.”
Allergan will continue to present the clinical value of Botox through various studies and solidify its position as a preventive treatment for chronic migraine headaches, Kim added.
The results of the research were published in the Journal of Headache and Pain.