Elagolix (ABT-620) for endometriosis pain?

Elagolix is an active brain hormone antagonist (called gonadotropin-releasing hormone which is acting on ovaries) has just completed clinical trial for endometriosis-associated pain. The review article by Alessandro et al in Archives of Gynecology and Obstetrics summarized the current research findings on Elagolix for the treatment of endometriosis.

Key Points

Highlight: Orally active gonadotropin-releasing hormone antagonist (Elagolix) may be useful for endometriosis-associated pain. 

Importance: Phase III trials demonstrated that Elagolix has the potential to be an important treatment option for endometriosis.

What's done here: This is a review article that summarized the findings of clinical studies evaluating the efficacy of Elagolix in patients with endometriosis.

Key Results:

• There are five clinical studies so far that have evaluated safety and efficacy of Elagolix in patients with endometriosis.
• Patients who received Elagolix a showed reduction in menstrual and non-menstrual pelvic pain in Phase 3 studies with nearly 1700 women.
• The drug was quite safe, with most adverse effects including hot flush, headache, and nausea.

Limitations: Long-term use of gonadotropin-releasing hormone therapies may have an impact on bone health.

Lay Summary

Elagolix is an orally active gonadotropin-releasing hormone antagonist that has just recently completed Phase 3 clinical trial for endometriosis-associated pain (NCT01931670).

The review article by Alessandro et al in Archives of Gynecology and Obstetrics summarized the current research findings on Elagolix for the treatment of endometriosis. To date, there are five clinical studies, including a phase 1 to evaluate the safety, two phase 2, and another two phase 3 studies to evaluate the efficacy in patients with endometriosis.

Focusing on the data from the latter Phase 3 studies with nearly 1700 women suffering moderate to severe endometriosis-associated pain, Elagolix a showed significant reduction in menstrual pain and non-menstrual pelvic pain compared to patients who received placebo. The treatment also improved the quality of life based on self-administered Endometriosis Health Profile (EHP-30) questionnaire.

The safety profile was found to be consistent across most studies, with most adverse effects including hot flush, headache, and nausea.

What are the mechanisms? This drug works by suppressing ovarian estrogen production. Apparently, in women with endometriosis-associated pain, it suppressed endometrial proliferation in a dose-dependent manner.

The results from these studies may warrant FDA approval. However, the concern with long term use of gonadotropin-releasing hormone therapies is their impact on bone health and this is an important consideration when using Elagolix.

The authors concluded that “The results of phase III trials demonstrate that Elagolix has the potential to be an important treatment option for women suffering from pain related to endometriosis

Research Source: https://www.ncbi.nlm.nih.gov/pubmed/28255765