Treatment with elagolix (AbbVie and Neurocrine Biosciences) was associated with sustained reduction in average monthly dysmenorrhea and non-menstrual pelvic pain through a 12-month treatment period, according to findings from two replicate Phase 3 extension studies (Elaris EM-I and Elaris EM-II). The data was presented at the American Society for Reproductive Medicine Scientific Congress & Expo (ASRM) in San Antonio.
The objective of the extension studies was to evaluate the long-term safety and efficacy of elagolix for the management of endometriosis with associated pain. Study participants were women 18–49 years of age with surgically diagnosed endometriosis and moderate to severe endometriosis-associated pain. The efficacy endpoints of the studies included the proportion of responders based on the average monthly dysmenorrhea and non-menstrual pelvic pain scores (measured by the Daily Assessment of Endometriosis Pain scale).
Across both extension studies, reductions in dysmenorrhea and non-menstrual pelvic pain following 6 months of elagolix treatment were maintained over 6 additional months of treatment. In addition, no new safety concerns were identified during the 12-month treatment period.
“The results presented today are positive for patients and are consistent with previous data that demonstrate elagolix has the potential to be an important non-surgical treatment option for women suffering from the most prevalent symptoms of endometriosis.” said Eric Surrey, MD, study investigator and Medical Director, Colorado Center of Reproductive Medicine.
Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, works through reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to decreased ovarian production of estradiol and progesterone.
Elagolix was granted Priority Review for endometriosis in the fourth quarter of 2017; Phase 3 trials for the management of uterine fibroids are ongoing.
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