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Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain
Date:3/25/2009

STUDY CONFIRMS EFFICACY IN VALIDATED ENDPOINTS; MIXED RESULTS IN EXPLORATORY ENDPOINTS

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SAN DIEGO, March 25 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line efficacy and safety results from its fourth Phase II clinical trial using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis. The 702 study (Lilac PETAL study) randomized 155 patients with a confirmed diagnosis of endometriosis into three treatment arms; elagolix 150 mg once daily, elagolix 250 mg once daily, or placebo. After completion of the initial three months of treatment, placebo recipients were re-randomized to elagolix for an additional three months. The top-line results reflect the three-month placebo-controlled portion of the study.

"It is clear from this study and all of our previous studies that elagolix is a safe and effective treatment for endometriosis sufferers," said Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "This Phase II study provides the information we need to continue to move this program forward. While limitations were discovered in some of the new exploratory efficacy measures, elagolix again showed strong efficacy in the historical validated endometriosis measures, with an excellent safety profile."

The Lilac PETAL study assessed endometriosis pain through a variety of measures, several of which were never before utilized in an endometriosis trial. These exploratory endpoints included three daily assessments using an electronic diary: a numeric rating scale (NRS) for pain (scale 0-10); a dysmenorrhea pain assessment (scale 0-3); and a non-menstrual
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SOURCE Neurocrine Biosciences, Inc.
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