Navigation Links
Neurocrine Biosciences Announces the Start of Second Phase III Study of Elagolix in Endometriosis
Date:8/29/2013

SAN DIEGO, Aug. 29, 2013 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the second Phase III pivotal trial to evaluate elagolix for the treatment of endometriosis has been initiated by AbbVie. This second Phase III trial is similar in design to the initial Phase III trial which is scheduled to provide top-line data in the third quarter of 2014 and complete in 2015.

"We are pleased that the second Phase III study in endometriosis has been launched," said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "The two Phase III trials will serve as the foundation for the anticipated NDA filing which is on track for 2016."

The second Phase III trial is a 24-week multinational, randomized double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 788 women, age 18-49, with moderate-to-severe endometriosis-associated pain. It will be conducted at more than 200 sites globally.

Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist, in development by AbbVie for the treatment of uterine fibroids and endometriosis. Neurocrine and AbbVie entered into a collaboration and license agreement for elagolix during 2010.

About Endometriosis

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.

About Elagolix

Elagolix inhibits gonadotropin 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. At the time of expected NDA filing for endometriosis, elagolix will have been studied in over 25 clinical trials and in excess of 3,000 subjects. A Phase IIb trial of elagolix for the treatment of uterine fibroids is also ongoing.

About Neurocrine Biosciences

Neurocrine Biosciences, Inc. is a clinical stage drug discovery company primarily focused on neurological and endocrine based diseases and disorders. The Company discovers and develops innovative pharmaceuticals, in diseases with high unmet medical needs or where the existing drug classes are inadequate, through a disciplined yet entrepreneurial process. Utilizing a portfolio approach to drug discovery, Neurocrine has multiple small molecule drug candidates at various stages of pharmaceutical development. Neurocrine's two lead late stage clinical programs are elagolix, a GnRH antagonist for women's health that is partnered with AbbVie Inc., and a wholly owned VMAT2 inhibitor for the treatment of movement disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the internet at http://www.neurocrine.com.

In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's business and finances in general, as well as risks and uncertainties associated with the Company's GnRH program and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company's GnRH program include, but are not limited to, risk that elagolix will not proceed to later stage clinical trials for uterine fibroids; risk that the elagolix clinical trials will fail to demonstrate that elagolix is safe and effective for the treatment of uterine fibroids; risk that elagolix uterine fibroid Phase III clinical trials will be delayed or not successfully initiated; risk that elagolix Phase III clinical trials will fail to demonstrate that elagolix is safe and effective for the treatment of endometriosis; risk associated with the Company's dependence on corporate collaborators for clinical development, commercial manufacturing and marketing and sales activities. With respect to its pipeline overall, the Company faces risk that it will be unable to raise additional funding required to complete development of all of its product candidates; risk relating to the Company's dependence on contract manufacturers for clinical drug supply; risks associated with the Company's dependence on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products; and the other risks described in the Company's report on Form 10-K for the year ended December 31, 2012 and report on Form 10-Q for the quarter ended June 30, 2013. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.


'/>"/>
SOURCE Neurocrine Biosciences, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Neurocrine Biosciences to Present at the Jefferies 2013 Global Healthcare Conference
2. Neurocrine Biosciences to Present At The Deutsche Bank 38th Annual dbAccess Health Care Conference
3. Neurocrine Biosciences Reports First Quarter 2013 Results
4. Neurocrine Biosciences to Present at the Needham 12th Annual Healthcare Conference
5. Neurocrine Biosciences Announces the Start of Phase IIb Study of Elagolix in Uterine Fibroids
6. Neurocrine Biosciences To Present At The 25th Annual Roth Conference
7. Neurocrine Biosciences To Present At The Cowen And Company 33rd Annual Health Care Conference
8. Neurocrine Biosciences To Present At The Leerink Swann Global Healthcare Conference 2013
9. Neurocrine Biosciences Announces Conference Call And Webcast To Present Fourth Quarter And Year-End 2012 Financial Results
10. Neurocrine Biosciences Announces Additional European And United States Patents Issued On Proprietary VMAT2 Inhibitor
11. Neurocrine Biosciences To Present At Deutsche Banks 2012 dbAccess BioFEST
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
(Date:6/23/2016)... Any dentist who has made an implant supported ... Many of them do not even offer this as a ... laboratory costs involved. And those who ARE able to offer ... high cost that the majority of today,s patients would not ... Zadeh , founder of Dental Evolutions Inc. and inventor of ...
(Date:6/23/2016)... startling report released today, National Safety Council research shows ... plan to eliminate prescription opioid overdoses. Prescription Nation ... the worst drug crisis in recorded U.S. history, assigned a "Making ... , New Mexico , Tennessee ... states, three – Michigan , Missouri ...
Breaking Medicine Technology:
(Date:6/27/2016)... Lafayette, California (PRWEB) , ... ... ... a pioneer in the patient payment industry today announced its strategic partnership ... and health system workflows. , The two companies’ proven, proprietary technology combine ...
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer ... they remain in the eye of the beholder, according to experts who offered insights ... American Journal of Managed Care. For the full issue, click here . , ...
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
Breaking Medicine News(10 mins):