Abbott Laboratories In Cooperation With Neurocrine Biosciences, Inc. Announces Initiation Of Phase 3 Study Of Elagolix In Patients With Endometriosis

Abbott Laboratories, in cooperation with Neurocrine Biosciences, Inc. announced the initiation of a pivotal Phase 3 clinical trial designed to evaluate the safety and efficacy of elagolix in female patients with endometriosis. Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist. The Phase 3 trial (M12-665) is a 24-week, multinational, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 875 women, age 18 to 49, with moderate-to-severe endometriosis-associated pain. It will be conducted at approximately 160 sites in the United States, Puerto Rico and Canada. A second pivotal Phase 3 study is planned with an NDA filing targeted in 2016. Elagolix inhibits gonadatropin releasing hormone (GnRH) receptors in the pituitary gland and ultimately reduces circulating sex hormone levels. To date, elagolix has been studied in over 20 clinical trials totaling more than 1,000 subjects. A Phase 2a trial of elagolix for the treatment of uterine fibroids is also ongoing.