AbbVie Pharmaceuticals has started a 24-week multinational, randomised double-blind, placebo-controlled second Phase III pivotal trial to evaluate elagolix to treat endometriosis.
Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist currently in development by AbbVie for the treatment of uterine fibroids and endometriosis.
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The investigational drug reduces gonadotropin releasing hormone (GnRH) receptors in the pituitary gland and ultimately reduces circulating sex hormone levels.
Neurocrine Biosciences and AbbVie have signed a collaboration and license agreement for elagolix in 2010.
The second Phase III trial, which will be similar in design to the first Phase III trial, is designed to evaluate the safety and efficacy of elagolix in 788 women aged between 18 and 49 with moderate-to-severe endometriosis-associated pain.
The study, which will be conducted at more than 200 sites worldwide, is expected to provide top-line data in the third quarter of 2014 and complete in 2015.
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By GlobalDataNeurocrine Biosciences president and CEO Kevin Gorman said: "The two Phase III trials will serve as the foundation for the anticipated NDA filing which is on track for 2016."
Elagolix has been studied in more than 20 clinical trials totalling more than 1,000 subjects to date and is expected to be further evaluated in more than 25 clinical trials and at least 3,000 subjects until NDA filing for endometriosis.
Meanwhile, a Phase IIb trial of elagolix for the treatment of uterine fibroids is ongoing.
