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Neurocrine Biosciences Completes 'Petal Study' Treatment Phase for Endometriosis
Date:6/17/2008

STUDY TO ASSESS IMPACT OF ELAGOLIX ON BONE MINERAL DENSITY

SAN DIEGO, June 17 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that the elagolix 0603 Phase IIb trial (Petal Study) has completed the 6-month treatment phase. The last subject completed her Week 24 study visit in early June. This Phase IIb trial assesses the impact of elagolix treatment on bone mineral density (BMD) as the primary endpoint using Dual Energy X-ray Absorptiometry (DXA) scans to document any change from baseline. In addition, efficacy assessments of endometriosis symptoms using the Composite Pelvic Sign and Symptoms Score (CPSSS) and Visual Analog Scale (VAS) are secondary endpoints.

"The Petal Study is an important trial for the elagolix program," says Christopher O'Brien, MD, Chief Medical Officer and Senior Vice President of Clinical Development. "For the first time we have the opportunity to examine the relationship between estradiol, n-telopeptide (a biomarker for bone resorption), elagolix plasma concentrations and BMD using DXA. We included a positive control, Depo-Provera, as one treatment arm in this randomized, double-blind, active comparator controlled trial to provide confidence that the trial would not miss subtle treatment-related effects," stated Dr. O'Brien.

"The recruitment process for the Petal Study confirms that endometriosis is an important, unmet medical need afflicting many women in the United States. Our call center received over 8,000 calls expressing interest in new treatments for endometriosis," reports Dr. O'Brien. A total of 252 women with endometriosis were randomized to one of three treatment arms: oral elagolix 150mg once daily, oral elagolix 75mg twice daily or Depo-P
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SOURCE Neurocrine Biosciences, Inc.
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