Abbott (NYSE: ABT), in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today 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.
"Endometriosis can be a debilitating disease that affects millions of women around the world and the exploration of new treatments could offer other options for women with this disease," said Dr. Hugh Taylor, M.D., Chief of Division of Reproductive Endocrinology and Infertility, Yale School of Medicine.
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.
"The investigation of elagolix for endometriosis is an important step in the exploration of potential treatments for this underserved patient population," said Rita Jain, M.D., divisional vice president, Pain, Respiratory and Metabolic Development, Global Pharmaceutical R&D, Abbott. "We are pleased to announce that the Phase 3 trial has begun screening for enrollment."
A second pivotal Phase 3 study is planned with an NDA filing targeted in 2016.
History of endometriosis and fibroids linked to higher long-term risk of early death