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Neurocrine Announces Top-Line Results From 703 Study (Tulip PETAL Study) of Elagolix for Treatment of Endometriosis Pain
Date:12/9/2009

bo and leuprorelin depot recipients were re-randomized in a double-blind manner to one of the elagolix arms for an additional three months. The top-line results reflect the initial three-month portion of the study. Unlike the previous Lilac PETAL Study (702 Study), the Tulip PETAL Study did not include a single-blind placebo lead-in phase prior to the first three months of treatment. The study was designed to compare active treatments to placebo and was not powered for active treatment group comparisons.

The study population overall had less severe endometriosis compared to the Company's prior endometriosis clinical trials; the mean Composite Pelvic Signs and Symptoms Scale (CPSSS) score was 8.1 (0-15 scale). The mean baseline daily score for Dysmenorrhea was 1.3, while the daily Non-Menstrual Pelvic Pain mean score was 0.89; both measured on a 0-3 scale.

Efficacy Endpoint Results


                                         Elagolix  Elagolix
LS Mean Change From Baseline    Placebo   150 mg    250 mg    Leuprorelin
----------------------------    -------  --------  --------   -----------
Non-Menstrual Pelvic Pain
 (mean daily score, 0-3)         -0.13    -0.27^    -0.28*       -0.32*
-------------------------        -----    ------    ------       ------
Dysmenorrhea
 (mean daily score, 0-3)         -0.30    -0.75**   -0.86**      -1.00**
------------------------         -----    -------   -------      -------

^ p=0.06, *p<0.05, **p<0.0001; (active vs. placebo)

The preliminary data confirm that elagolix and leuprorelin are associated with reductions in Dysmenorrhea and Non-Menstrual Pelvic Pain daily scores when compared to placebo. As shown with all previous elagolix trials, symptoms of dysmenorrhea improved significantly in both elagolix treatment groups and with leuprorelin compared to placebo (p<0.0001). Additionally, the percentage of dysmenorrhea pain-free days was markedly higher
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SOURCE Neurocrine Biosciences, Inc.
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