Shares of Allergan shot up 13 percent on the news that Botox worked as a therapy for chronic migraines in a late-stage trial. And based on its analysis from two studies, Allergan says it will go to the FDA next year to file an sBLA for an added approval.
Botox is a well known toxin that smooths wrinkles. In one Phase III trial, there was no difference between Botox and a placebo in the number of episodes of headache, but there was a reduction in the number of days volunteers suffered from a headache in the Botox arm. Researchers then changed the primary endpoint of the second late-stage trial to a reduction in the number of headache days. In that study the Botox arm reported a significant reduction in both headache episodes and headache days.
"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," said Scott Whitcup, MD, Allergan's EVP, research and development. "It is gratifying to focus our research and development efforts on an indication that addresses such an important unmet medical need."
- here's Allergan's release