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Neurocrine Announces Phase IIb Results Of VMAT2 Inhibitor NBI-98854 For Treatment Of Tardive Dyskinesia
Date:9/9/2013

SAN DIEGO, Sept. 9, 2013 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the 50mg dose of NBI-98854, a small molecule VMAT2 inhibitor in development for tardive dyskinesia, did not meet the primary endpoint in the Phase IIb Kinect study while the 100mg dose showed a statistical and clinically significant improvement. The pre-specified primary endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 in the intent-to-treat (ITT) population.

Although the 50mg dose of NBI-98854 did not reach statistical significance for the primary endpoint at Week 6, the 100mg dose, utilizing the blinded central video AIMS assessment, showed a statistically significant and clinically meaningful reduction in tardive dyskinesia symptoms at Week 2 (the end of the 100mg dose interval). AIMS scores were reduced by 5.5 points in the 100mg per-protocol (PP) group compared to a reduction of 2.7 points in placebo (p=0.008), and the responder rate (>= 50% improvement from baseline) was 48% in the 100mg group compared to 23% in placebo (p=0.034). The 100mg dose was expected to be a maximum tolerated dose based on earlier data; however in this patient population, 100mg was well tolerated. The pre-specified statistical analysis plan included three data sets: safety set (all subjects with at least one dose), ITT set (all randomized subjects with at least one AIMS assessment) and the PP set (all subjects except those with no detectable drug levels at the evaluation time point).

"Although this was not the result we anticipated in the 50mg dose based on the data set from the earlier clinical studies, we were pleased to see a clear dose related response at the end of Week 2, with the 100mg dose, " said Kevin C. Gorman, President and Chief Executive Officer of Neuroc
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SOURCE Neurocrine Biosciences, Inc.
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