Navigation Links
Neurocrine Announces Top-Line Results of Corticotropin Releasing Factor Antagonist GSK561679 for Treatment of Major Depressive Disorder

SAN DIEGO, Sept. 14 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line efficacy and safety results from a Phase II clinical trial utilizing Corticotropin Releasing Factor (CRF1) receptor antagonist GSK561679 in patients currently experiencing a major depressive episode.  This double-blind, placebo controlled trial randomized 150 patients into two treatment arms, 350 mg of GSK561679 daily and placebo, and was conducted in the United States by GlaxoSmithKline (GSK) under the GSK/Neurocrine CRF1 collaboration. The primary endpoint was change from baseline in the Bech Melancholia scale at Week 6 and a key secondary endpoint was change from baseline in the HAMD-17 scale at Week 6.

Results of statistical analysis using the intent-to-treat population revealed no benefit of GSK561679 compared with placebo on both the Bech Melancholia and HAMD-17 endpoints. The top-line results are based on the six week placebo-controlled portion of the study for the intent to treat population of 145 patients. From a safety perspective, there were no significant adverse events, and the drug was generally well tolerated.

"It is clear from this study that CRF1 remains a difficult drug target in the drive to improve current pharmaceutical therapies for depression," said Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences.  "We plan to meet with GSK in the coming months after the full clinical data set is complete to determine the next steps for the CRF depression program."

Three separate academic collaborative clinical trials are ongoing to evaluate the effects of GSK561679 in Post Traumatic Stress Disorder, anxiety and alcoholism.

Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including endometriosis, anxiety, depression, pain, diabetes, irritable bowel syndrome, insomnia, and other neurological and endocrine related diseases and disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the internet at

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 CRF program and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company's CRF program include, but are not limited to, risk that GSK may terminate its development of GSK561679 and/or its collaboration with the Company;  risk that the ongoing GSK561679 clinical trials will fail to demonstrate that GSK561679 is safe and effective; risk that the Company's CRF program backup product candidates will not prove suitable for clinical development; risk that the Company will be unable to raise additional funding required to complete development of its CRF program product candidates; risk associated with the Company's dependence on corporate partners for future clinical development, 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 CRF program products; and the other risks described in the Company's report on Form 10-K for the year ended December 31, 2009 and reports on Form 10-Q for the quarter ended June 30, 2010. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.

SOURCE Neurocrine Biosciences, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Neurocrine Biosciences Announces Conference Call and Webcast to Report Second Quarter 2010 Financial Results
2. -- Neurocrine Announces a Second Corporate Collaboration Within Twenty-Four Hours -- Neurocrine Biosciences Announces a Worldwide Collaboration With Boehringer Ingelheim to Research and Develop GPR119 Agonists for Type II Diabetes
3. Neurocrine Biosciences to Present at the Deutsche Bank 35th Annual Health Care Conference
4. Neurocrine Biosciences to Present at the 30th Annual Cowen & Co. Health Care Conference
5. Neurocrine Biosciences, Inc. Prices Common Stock Offering
6. Neurocrine Announces Proposed Public Offering of Common Stock
7. Neurocrine Advances VMAT2 Inhibitor Program
8. Neurocrine Biosciences to Present at the 21st Annual Piper Jaffray Health Care Conference
9. Neurocrine Biosciences Reports Third Quarter 2009 Results
10. Neurocrine Biosciences Announces Conference Call and Webcast to Present Third Quarter 2009 Financial Results
11. Neurocrine Biosciences Presents Elagolix Data
Post Your Comments:
(Date:11/24/2015)... Va. , Nov. 24, 2015  DILON Diagnostics ... have signed an agreement for DILON to distribute GE,s ... across the globe. The signing of this distribution agreement will ... NM750b Molecular Breast Imaging system and is considered an ... provide better healthcare solutions for clinicians and their patients. ...
(Date:11/24/2015)... 24, 2015 Avery Biomedical Devices (ABD), manufacturer ... announce the appointment of Anders Jonzon , MD; ... Dr. Jonzon is a Physiologist ... Hospital, Uppsala University, Uppsala and Children,s Hospital, Karolinska, ... a fellow at the Cardiovascular Institute (UCSF). His research ...
(Date:11/24/2015)... LAUSANNE and BERN, Switzerland ... SA, the ARTORG Center for Biomedical Engineering Research of ... and the Division of Endocrinology, Diabetes and Clinical Nutrition ... announce the start of an exclusive collaboration to develop ... control algorithm for the personalised delivery of insulin for ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... 24, 2015 , ... World Patent Marketing , a ... invention that revolutionizes the vending machine industry by providing healthy and fresh smoothies ... billion," says Scott Cooper, CEO and Creative Director of World Patent Marketing. "Shakes ...
(Date:11/24/2015)... IL (PRWEB) , ... November 24, 2015 , ... ... and engineer of patented products, announces Fragrance by Marcelle, a cosmetic invention which ... The Perfume & Fragrance Manufacturing Market in the US is worth $3 billion ...
(Date:11/24/2015)... ... ... thrilled, as a newbie here, to leave a mark for the entire staff,” exclaimed 4th ... California Casualty . Stephanie is in her fifth year teaching at Santan Elementary School ... is such an amazing school and we deserve a space where we can go to ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... There’s nothing ... containers that gardeners of all levels can enjoy. , This year, gardens are ... can fulfill anyone’s outdoor living needs. , Vita Gardens’ African Keyhole Garden Bed ...
(Date:11/24/2015)... , ... November 24, 2015 , ... On the pleasant ... the second annual Glenholme 5K Run for Autism held at Steep Rock ... in the state, was hailed as another remarkable triumph. , Created and hosted by ...
Breaking Medicine News(10 mins):