Clinical Evaluation of the Oral Gonadotropin-Releasing Hormone-Antagonist Elagolix for the Management of Endometriosis-Associated Pain

Abstract

Endometriosis is an estrogen-dependent chronic inflammatory disease associated with pelvic pain symptoms that are often severe, mainly dysmenorrhea, nonmenstrual pelvic pain and dyspareunia. This condition is also associated with peripheral and central sensitization. The current medical treatment options for endometriosis-associated pain are limited. Recently, the US FDA approved the novel, oral, nonpeptide gonadotropin-releasing hormone antagonist elagolix for the management of moderate to severe endometriosis-associated pain. Elagolix produces dose-dependent estrogen suppression, from partial suppression at lower doses to nearly full suppression at higher doses. This review article summarizes the current understanding of the pathophysiology of endometriosis, with a focus on the role of estrogen and the mechanisms of pain symptoms, and reviews the clinical development of elagolix in women with endometriosis-associated pain.

Keywords::

• chronic pelvic pain
• dysmenorrhea
• dyspareunia
• elagolix
• endometriosis
• endometriosis-associated chronic pain
• estradiol
• estrogen suppression
• GnRH antagonist
• nonmenstrual pelvic pain

Financial & competing interests disclosure

AbbVie Inc. funded the elagolix research reviewed in this article and participated in the review and approval of this publication. HS Taylor has served as a consultant for AbbVie, Bayer, ObsEva and DotLab and is funded by the NIH. K Chwalisz is an employee of AbbVie, receiving stock or stock/options. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Editorial support, funded by AbbVie, was provided by MJ Theisen, of Complete Publication Solutions LLC (PA, USA).

Additional information

Funding

AbbVie Inc. funded the elagolix research reviewed in this article and participated in the review and approval of this publication. HS Taylor has served as a consultant for AbbVie, Bayer, ObsEva and DotLab and is funded by the NIH. K Chwalisz is an employee of AbbVie, receiving stock or stock/options. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Editorial support, funded by AbbVie, was provided by MJ Theisen, of Complete Publication Solutions LLC (PA, USA).