GnRH Receptor Antagonist Elagolix Offers Hope for Patients With Endometriosis

MedicalResearch.com Interview with:

Hugh S. Taylor, MD Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology; Chair of Obstetrics Gynecology, and Reproductive Sciences, Yale School of Medicine Chief of Obstetrics and Gynecology Yale-New Haven Hospital

Dr. Hugh S. Taylor

Hugh S. Taylor, MD
Anita O’Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology; Chair 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: The abstract presented at ASRM featured results from two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer from endometriosis. Elagolix is an investigational, orally administered, gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone and follicle-stimulating hormone secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.

The data 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) and non-menstrual pelvic pain 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.

MedicalResearch.com: What should readers take away from your report?

Response: Endometriosis affects an estimated one in 10 women and can have significant impact on patient function and quality of life. Symptoms can disrupt routine activities such as going to work or spending time with friends and family. The data presented at ASRM are encouraging for patients and demonstrate that Elagolix has the potential to be an important treatment option for women suffering from pain related to endometriosis.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: There is no cure for endometriosis and there have been few recent scientific advancements for patients suffering from endometriosis. Endometriosis-associated pain is currently managed with oral contraceptives, progestins, danazol, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids and GnRH agonists, many of which are not specifically indicated for the treatment of endometriosis. In more extensive cases, surgical interventions (e.g., laparotomy or laparoscopy) are often pursued, and may not be curative for all individuals.

Currently, physicians have limited options for the long-term medical management of endometriosis and are in need of additional treatment options to help manage this chronic and painful disease.

MedicalResearch.com: Is there anything else you would like to add?

Response: Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis. 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.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

*This work was supported by AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc.

Citation:

72nd American Society for Reproductive Medicine Scientific Congress abstract:
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; Taylor H, et al.; Abstract #P440; Poster Session; Wednesday, October, 19, 2016; 7:00AM – 8:45AM MDT

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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