AbbVie will present new detailed results of primary and secondary efficacy and safety data from two pivotal Phase 3 studies of elagolix in endometriosis-related pain, and on the economic burden of endometriosis and related surgery in women in the U.S.
The presentations will take place at the 72nd American Society for Reproductive Medicine Scientific Congress & Expo (ASRM) Oct. 15-19 in Salt Lake City in cooperation with Neurocrine Biosciences.
Elagolix is a gonadotropin-releasing hormone (GnRH) antagonist, orally administered, that blocks GnRH signaling by binding to the hormone’s receptors in the pituitary gland. Elagolix is currently under investigation in diseases that are mediated by sex hormones like uterine fibroids and endometriosis. Elagolix has so far been assessed in over 40 clinical trials, and in more than 3,000 subjects.
“Endometriosis affects an estimated one in 10 women, and physicians and their patients are seeking alternative options to help relieve symptoms of this disease,” Dr. Rob Scott, MD, vice president of development and chief medical officer at AbbVie, said in a press release. “The data highlights the efficacy and safety profile of elagolix in the treatment of pain associated with endometriosis, and underscores AbbVie’s efforts to help address the needs of women suffering from endometriosis.”
Here are AbbVie’s oral presentations:
- (Abstract #O232) “The Effect of Elagolix on the Endometrium: Safety Results From Two Randomized, Placebo-Controlled Studies in Women with Endometriosis-Associated Pain”; 11:15 a.m. to 12:45 p.m. Oct. 19.
- (Abstract #O229) “The Impact of Elagolix on Quality of Life in Women with Endometriosis-Associated Pain: Results From Two Randomized, Placebo-Controlled Studies Using the Endometriosis Health Profile Questionnaire”; 11:15 a.m. to 12:45 p.m. Oct. 19.
- (Abstract #O230) “Direct and Indirect Costs Associated with Endometriosis-Related Surgery Among Employed Women in the US”; 11:15 a.m. to 12:45 p.m. Oct. 19.
AbbVie’s poster presentations include:
- (Abstract #P440) “Elagolix, An Oral Gonadotropin-Releasing Hormone (GnRH) Antagonist, For The Management Of Endometriosis-Associated Pain: Safety And Efficacy Results From Two Double-Blind, Randomized, Placebo-Controlled Studies” – 7 a.m. to 8:45 a.m. Oct. 19.
- (Abstract #P434) “Use Of Elagolix For The Management Of Endometriosis-Associated Pain: Secondary Efficacy Results From Two Randomized, Placebo-Controlled Studies”; 7 a.m. to 8:45 a.m. Oct. 19.
- (Abstract #P455) “The Effect Of Elagolix On Bone Mineral Density: Safety Results From Two Randomized, Placebo-Controlled Studies In Women With Endometriosis-Associated Pain”; 7 a.m. to 8:45 a.m. Oct. 19.
- (Abstract #P432) “Incremental Costs of Healthcare and Work Loss Attributed to Endometriosis in a Cohort of Commercially Insured Women”; 7 a.m. to 8:45 a.m. Oct. 19.
- (Abstract # P457) “Incidence of Comorbidities Among Women with Endometriosis: A Retrospective Matched Cohort Study”; 7 a.m. to 8:45 a.m. Oct. 19.