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AbbVie says Elagolix reduces pelvic pain in two phase 3 extension studies

PBR Staff Writer Published 02 November 2017

AbbVie said that its gonadotropin-releasing hormone (GnRH) antagonist elagolix demonstrated sustained reduction in average monthly menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse in two replicate Phase 3 extension studies.

The objective of the Elaris EM­III and Elaris EM­IV extension studies was to assess the long-term safety and efficacy of elagolix for the management of endometriosis with associated pain..

The GnRH receptor antagonist, which is to be administered orally, is a short-acting molecule that prevents endogenous GnRH signaling by binding competitively to GnRH receptors found in the pituitary gland.

Elagolix’ safety and tolerability was found to be on par with the expected effects of reduced estradiol levels in the extension studies. Also, no new safety concerns were recorded with the use of elagolix throughout the treatment period, stated AbbVie.

The company noted that the efficacy endpoints of the two crucial trials were the percentage of responders based on the average monthly menstrual pain (dysmenorrhea) and non-menstrual pelvic pain scores, as measured by the Daily Assessment of Endometriosis Pain scale.

AbbVie reported that after six months of elagolix treatment, the reductions in dysmenorrhea and non-menstrual pelvic pain were sustained over six more months of treatment in both the extension trials for 150mg once daily (QD) and 200mg twice daily (BID) doses of the drug.

For both doses, over 50% of women were responders for dysmenorrhea and non-menstrual pelvic pain.

For painful intercourse (dyspareunia), the responder rate following 12 months of treatment with the 200mg BID dose was found to be higher than with 150mg QD dose.

AbbVie therapeutic areas and international development vice president Shao-Lee Lin said: “An estimated one in 10 women of reproductive age have endometriosis.

“There have been few recent scientific advancements for women suffering from endometriosis and physicians are in need of additional treatment options to help manage this debilitating disease.”

Last month, elagolix was granted priority review by the US Food and Drug Administration (FDA) for the management of endometriosis with associated pain.

Image: US Headquarters of AbbVie in Lake Bluff, Illinois. Photo: courtesy of AbbVie Inc.