Elagolix in endometriosis-related pain: a profile of its use as approved in the USA
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Elagolix (Orilissa™), an oral non-peptide gonadotropin-releasing hormone receptor antagonist, is approved for the management of moderate to severe pain associated with endometriosis in the USA and Canada. It reduces levels of gonadotropins, thereby suppressing ovarian sex hormones, ovulation, and endometrial proliferation. In phase 3 trials in women with moderate to severe endometriosis-related pain, elagolix 150 mg once daily and 200 mg twice daily improved clinical response rates for dysmenorrhea and non-menstrual pelvic pain to a significantly greater extent than placebo at 3 and 6 months of treatment. Improvements from baseline in several other endometriosis pain-related outcomes were also better with elagolix than with placebo, with the benefits of treatment being maintained with treatment for an additional 6 months in extension studies. Elagolix is generally well tolerated, with most adverse events being of mild to moderate severity. However, elagolix is associated with a dosage-dependent risk of bone loss, which limits its duration of therapy, use in at-risk patients, and concomitant use with certain drugs.
The manuscript was reviewed by S. Ferrero, Academic Unit of Obstetrics and Gynecology, IRCCS Ospedale Policlinico San Martino, Genova, Italy, and others. During the peer review process, AbbVie Inc., the marketing-authorization holder of elagolix, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with ethical standards
The preparation of this review was not supported by any external funding.
Conflict of interest
K.A. Lyseng-Williamson is an employee of Adis/Springer, is responsible for the article content and declares no conflicts of interest.
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