SAN DIEGO, Dec. 9 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line efficacy and safety results from the Tulip PETAL Study (703 Study), its fifth Phase 2 clinical trial using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.
"The efficacy and safety data from the Tulip PETAL Study are consistent with what we have seen in our previous elagolix studies. Women recognize significant improvement in endometriosis symptoms across multiple time points using elagolix, coupled with an excellent safety profile," said Chris O'Brien, M.D., Chief Medical Officer at Neurocrine. "Although certain daily efficacy scales employed in this trial will not be used in subsequent trials, we have and will continue to obtain important information from this Phase 2 study. Given the placebo response in some of the secondary efficacy endpoints, we plan to perform extensive analyses to understand the differences between North American and Central Eastern European clinical trial sites and subjects, the impact of trial design differences and patient baseline characteristics, and continue our assessment of appropriate statistical methods as we plan for our pivotal trials."
Tulip PETAL Study Design and Baseline Characteristics
The Tulip PETAL study was conducted in six countries in the Eastern European region (Romania, Poland, Ukraine, Hungary, Russia and Bulgaria). The study randomized 174 patients with a laparoscopic diagnosis of endometriosis into four treatment arms: elagolix 150 mg once daily, elagolix 250 mg once daily, leuprorelin monthly depot (Prostap SR®), or placebo; in a double-blind, double-dummy design. After completion of the initial three months of treatment, place
|SOURCE Neurocrine Biosciences, Inc.|
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