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Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis
Date:9/2/2008

* -3.7* -3.8*

Week 24 mean -5.5* -5.2* -5.3*

Dysmenorrhea 2.4

Week 24 mean -1.5* -1.4* -1.7*

Responder Rate 86% 74% 86%

Non-Menstrual Pelvic

Pain 2.2

Week 24 mean -1.2* -1.2* -1.1*

Responder Rate 86% 77% 77%

VAS 78.7

Week 24 mean -31.8* -33.4* -35.5*

*ITT Analysis, p<0.0001

"We have treated over 600 subjects with elagolix in our extensive endometriosis clinical program, and have consistently seen a robust reduction in endometriosis pain using multiple outcome measures. In our previous Phase II studies we have shown rapid onset of action and sustained efficacy over three months. This study extends those findings, demonstrating significant and sustained pain reduction for six months," said Dr. O'Brien. "There is much more data to come from this study once patients complete the six month follow-up and the study is unblinded at an individual patient level. At that time we will be able to make correlations between pain scores, BMD, pharmacokinetic values, and hormonal levels on an individual patient basis, and we look forward to also sharing those results, as soon as they are available."

Treatment with elagolix was also safe and generally well tolerated. Discontinuation from the clinical trial due to adverse events (AE) was more common among women randomized to DMPA (16%) than those receiving elagolix 150 mg once daily (5%) or 75 mg twice daily (7%). This increased discontinuation in women randomized to DMPA was primarily attributable to irregular vaginal bleeding. The overall rate of AE reporting was comparable across all groups. The most common AE was headache;
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SOURCE Neurocrine Biosciences, Inc.
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