21 May Phase 3 Studies Demonstrate Reduce Endometriosis-Associated Pain with Elagolix
MedicalResearch.com Interview with:
Hugh S. Taylor, M.D.
Anitta O’keeffe Young Professor and Chair
Departemnt of Obstetrics, Gynecology and Reproductive Sciences
Yale School of Medicine
Chief of Obstetrics and Gynecology
Yale-New Haven Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Elagolix is an investigational, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.
Data from two replicate Phase 3 studies evaluating the efficacy and safety of elagolix were published in the New England Journal of Medicine. Elagolix demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of elagolix was consistent across both Phase 3 trials and also consistent with prior elagolix studies.
Ultimately, the studies showed that both elagolix doses (150 mg QD and 200 mg BID) were effective in improving dysmenorrhea, non-menstrual pelvic pain and quality of life over 6 months in women with endometriosis-associated pain. The elagolix safety/tolerability profile was consistent with the mechanism of action.
MedicalResearch.com: What should readers take away from your report?
Response: There is no cure for endometriosis and patients are in need of additional treatment options to help manage this chronic and painful disease. Together, the two Phase 3 studies evaluated the safety and efficacy of elagolix in nearly 1,700 women with moderate-to-severe endometriosis-associated pain, representing the largest prospective randomized endometriosis trials conducted to date.
The study results presented in NEJM highlight the efficacy and safety profile of elagolix and demonstrate its potential to be an important treatment option for women suffering from endometriosis. According to the data, elagolix may offer reduced side effects and the two doses could offer patients different options to meet their own needs.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Currently, physicians have limited options for the long-term medical management of endometriosis and there have been few recent scientific advancements for women living with this disease.
While endometriosis cannot be cured, it can be managed and more research is needed to offer better long-term care for women living with endometriosis, with the goal of reducing endometriosis-associated pain and improving quality of life.
Disclosures: Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis. Elagolix is a short-acting molecule that works by partially lowering the level of ovarian sex hormones in the body and allows for dose-dependent modulation of estradiol concentrations. Elagolix directly inhibits GnRH receptors, which may lead to an inhibition of receptor signaling.
I have received research support from OvaScience and Pfizer and served as a consultant for AbbVie, Pfizer, Bayer, Therapeutics MD, Perrigo and OvaScience.
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