Posted by Michael Wonder on 06 Sep 2017
AbbVie submits new drug application to U.S. FDA for investigational oral treatment elagolix for the management of endometriosis with associated pain
6 September 2017 - If approved by the FDA, elagolix will be the first new medical management treatment option for endometriosis-associated pain in more than a decade.
AbbVie announced that it has submitted a new drug application to the U.S. FDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, being evaluated for the management of endometriosis with associated pain.
In two replicate Phase 3 clinical studies, elagolix demonstrated superiority compared to placebo in reducing three types of endometriosis-associated pain – daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.
