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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

in the elagolix treatment groups when compared to placebo (elagolix 150 mg, elagolix 250 mg, and leuprorelin, p<0.0001). Although statistical significance was achieved with the non-menstrual pelvic pain scale in this trial, the numeric changes are small, the dynamic range of the scale is small and, as previously stated, we do not intend to use this scale in subsequent trials.

Additional Efficacy Endpoint Results

The Patient Global Impression of Change showed a significant improvement at both Week 4 and Week 8 for the elagolix and leuprorelin arms, but the study had an unexpectedly high placebo effect in Week 12. On this 1-7 scale, a score of 4 is "no change," 3 is "minimally improved," 2 is "much improved," and 1 is "very much improved."



Patient Global Impression of Change
 Mean Score                               Week 4   Week 8   Week 12
-----------------------------------       ------   ------   -------
Placebo                                     3.4      2.8       2.6
-------                                     ---      ---       ---
Elagolix 150mg                              3.0*     2.5       2.4
---------------------                       ----     ---       ---
Elagolix 250mg                              2.9*     2.2*      2.2
--------------                              ----     ----      ---
Leuprorelin                                 3.3      2.3*      2.1*
-----------                                 ---      ----      ----

*p<0.05; (active vs. placebo)

While the magnitude of improvement was similar to that in previous studies with elagolix, it appears that differences in population and study design may have contributed to the larger than expected response in the placebo recipients at Week 12. Full unblinding at the individual subject level, after the Week 30 visit, will allow for a detailed analysis of the nuances in the Week 12 placebo response with this scale.


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SOURCE Neurocrine Biosciences, Inc.
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