Abbott, in cooperation with Neurocrine Biosciences, Inc. has initiated a pivotal phase III 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.

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 totalling more than 1,000 subjects. A phase II a trial of elagolix for the treatment of uterine fibroids is also ongoing.

"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, MD, Chief of Division of Reproductive Endocrinology and Infertility, Yale School of Medicine.

The phase III 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, MD, divisional vice president, Pain, Respiratory and Metabolic Development, Global Pharmaceutical R&D, Abbott. "We are pleased to announce that the phase III trial has begun screening for enrollment."

A second pivotal phase III study is planned with an NDA filing targeted in 2016.

Endometriosis is associated with a multitude of symptoms, some of the most common of which include pain related both to menstruation (dysmenorrhea) as well as chronic pelvic pain throughout the menstrual cycle, and is a leading cause of infertility. The World Endometriosis Research Foundation estimates that there are approximately 100 million women worldwide who suffer from endometriosis. The annual direct and indirect costs of endometriosis are estimated to exceed $20 billion in the United States alone.

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