Navigation Links
Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients With Endometriosis
Date:7/29/2009

SAN DIEGO, July 29 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new six month safety and efficacy results from its fourth Phase II clinical trial using its proprietary, orally-active non-peptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis. Consistent with previously reported six month (Petal Study) and three month (Lilac Petal Study) results, a favorable safety profile and clinically meaningful efficacy have again been confirmed through month six of the Lilac Petal Study. This newly available data also provides clinical confirmation of Neurocrine's extensive pharmacologic modeling related to the elagolix dose-response continuum. The outcome of primary interest at month six was the impact of the elagolix 250 mg dose on bone mineral density (BMD) as measured by dual energy X-ray absorptiometry (DXA) scanning.

Over the six month treatment period, elagolix 150 mg once daily had minimal impact on BMD (-0.80% mean change from baseline, femur; -0.66% mean change from baseline, spine). The 250 mg once daily dose, as expected, had slightly greater percentage change from baseline at month six (-1.0% femur, -1.6% spine). The 150 mg once daily BMD profile in this Lilac Petal Study is consistent with that previously demonstrated in the six-month Petal Study.

"We selected the 150 mg and 250 mg once daily doses for this study based upon predictions generated from extensive modeling of dose, estradiol and bone mineral density relationships. Prior to this study we anticipated that the 250 mg dose would provide exposure such that we would start to see an increased impact on bone mineral density in a small portion of study subjects. The Lilac Petal data confirm that our modeling of the dose-response curve was accurate," said C
'/>"/>

SOURCE Neurocrine Biosciences, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Oncolytics Biotech Inc. Successfully Completes 100-Litre cGMP Production of REOLYSIN(R)
2. Blue Marble Energy Corp. Announces Successful Close of Series A Financing
3. EnVivo Pharmaceuticals Announces Results and Successful Completion of EVP-6124 Phase Ib/IIa Trial at the International Conference on Alzheimers Disease
4. Funxional Successfully Completes Initial Clinical Trial of FX125L, an Anti-Inflammatory Drug With a Novel Mechanism of Action
5. Enigma Diagnostics Announces Successful Evaluation of the Enigma FL by the UKs Veterinary Laboratories Agency
6. PharmaVentures Assists Helsinn in the Successful Sale of Helsinn Chemicals Ireland to the Medinco C.F.M. Group
7. Successful Field-Trial Remediation of 1,2-DCA and VC Contaminated Groundwater in Northern Italy
8. Orthocrat Announces Successful Implementation of TraumaCad at UPMC Mercy
9. Successful Phase I/II Clinical Trial Results From Cancer Patients Treated With Anti-Cancer Drug From Axelar AB
10. Symphony Medical Announces First Patient Successfully Treated With Novel Congestive Heart Failure Therapy
11. Zenobia Therapeutics Successfully Completes Initial Phase of Its Service Agreement With Syntonix Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... BOSTON (PRWEB) , ... October 12, 2017 , ... ... name for two-dimensional representations of a complex biological network, a depiction of a ... a big mess,” said Dmitry Korkin, PhD, associate professor of computer science at ...
(Date:10/12/2017)... ... October 12, 2017 , ... AMRI, ... and biotechnology industries to improve patient outcomes and quality of life, will now ... testing are being attributed to new regulatory requirements for all new drug products, ...
(Date:10/11/2017)... ... October 11, 2017 , ... ComplianceOnline’s Medical Device Summit is back for its ... 2018 in San Francisco, CA. The Summit brings together current and former FDA office ... directors and government officials from around the world to address key issues in device ...
(Date:10/11/2017)... ... October 11, 2017 , ... A new ... rates in frozen and fresh in vitro fertilization (IVF) transfer cycles. ... to IVF success. , After comparing the results from the fresh and frozen ...
Breaking Biology Technology:
(Date:4/5/2017)... , April 5, 2017 Today ... announcing that the server component of the HYPR platform ... for providing the end-to-end security architecture that empowers biometric ... HYPR has already secured over 15 million users ... including manufacturers of connected home product suites and physical ...
(Date:3/30/2017)... The research team of The Hong Kong ... identification by adopting ground breaking 3D fingerprint minutiae recovery and matching ... and accuracy for use in identification, crime investigation, immigration control, security ... ... A research team led by ...
(Date:3/24/2017)... 24, 2017 The Controller General of Immigration from ... Abdulla Algeen have received the prestigious international IAIR Award for the ... Continue Reading ... ... Controller Abdulla Algeen (small picture on the right) have received the IAIR ...
Breaking Biology News(10 mins):