AbbVie and Neurocrine Biosciences have reported positive results from two replicate pivotal Phase III clinical trials of Elagolix to treat premenopausal women suffering from endometriosis.
Endometrosis is a condition when cells that normally line up the uterus begin to grow outside of the uterus resulting in chronic pelvic pain, pain during intercourse and increased pain during menses.
Elagolix is an orally administered, short-acting molecule and has been developed as a gonadotropin-releasing hormone (GnRH) receptor antagonist.
It inhibits the endogenous GnRH signalling by fusing competitively to GnRH receptors in the pituitary gland.
Its administration results in rapid, reversible, dose-dependent inhibition of luteinising hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, during therapy.
The two Phase III M12-665 and M12-671 trials were conducted as a randomised, double-blind, placebo-controlled study, which were aimed at testing the safety and efficacy of Elagolix while examining 1,700 women with moderate-to-severe endometriosis-associated pain.
Results of the studies suggested the efficacy of Elagolix over placebo in reducing menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis.
It was determined on the basis of Daily Assessment of Endometriosis Pain scale.
Elagolix has also demonstrated a safety profile, which was consistent with the previously conducted studies.
AbbVie development vice-president and chief medical officer Rob Scott said: "These results from the largest clinical trials ever conducted in endometriosis support AbbVie's continued efforts to pursue regulatory filing of Elagolix as a potential new treatment option for the disease's most prevalent symptoms.
"There have been few recent scientific advancements for patients suffering from endometriosis and physicians are in need of additional treatment options to help manage this chronic and painful disease."