Neurocrine Biosciences Announces Successful Elagolix PETAL Study in End...(this was reported 35times by 19 women (2...),Health

Date:9/2/2008

this was reported 35 times by 19 women (23%) randomized to elagolix 150 mg once daily, 52 times by 22 women (26%) randomized to elagolix 75 mg twice daily, and 43 times by 12 (14%) women randomized to DMPA. There were two serious AEs that led to discontinuation from the trial, both in the DMPA group. The mean frequency of hot flashes was comparable in both the screening period and the treatment period, approximately 0.5 per day across all treatment groups, consistent with our prior Phase II studies.

"We couldn't be more pleased with the results of this study," said Kevin C. Gorman, President and Chief Executive Officer, Neurocrine Biosciences. "We began this program nine years ago with the hope of selectively modulating the GnRH system with an oral antagonist. This trial and our previous Phase II studies have now shown that this is possible. Elagolix is a first in class drug for endometriosis sufferers who desperately need a safe and effective therapy. This is apparent from the 8,000 inquiries to the call center for just this one study. Additionally, to date we had more than 6,000 inquiries regarding the ongoing Lilac PETAL study which is now fully enrolled and on track to report results in 2009."

"These study results are very encouraging," said Shayne M. Plosker, MD, Associate Professor and Division Director, of USF IVF and Reproductive Endocrinology at the University of South Florida College of Medicine in Tampa. "Elagolix has the potential to be an ideal advanced medical therapy for endometriosis-associated pelvic pain and dysmenorrhea. Intermediate suppression of estradiol by a well-tolerated drug appears attainable affording endometriosis symptom reduction without bone loss."

Neurocrine Biosciences would like to thank the patients and the investigators for participating in this important clinical trial.

Conference Call and Webcast Information

The Company will host a live conference call and webcast to provide additional detai
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SOURCE Neurocrine Biosciences, Inc. Copyright©2008 PR Newswire. All rights reserved

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