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Neurocrine Announces 12-Week Safety Results From Initial Phase IIB Study Of VMAT2 Inhibitor NBI-98854
Date:1/9/2014

requency.

Participants were assessed utilizing the Barnes Akathisia Ratings Scale (BARS) for akathisia and the Simpson-Angus Scale (SAS) for parkinsonism.  Both of these scales documented minimal symptoms at baseline and were stable to improved during the twelve weeks of treatment.  Subjects were also assessed using various safety scales including the Positive and Negative Syndrome Scale (PANSS) for Schizophrenia, the Calgary Depression Scale for Schizophrenia and the Columbia-Suicide Severity Rating Scale (C-SSRS); all of these scores were stable to improved from baseline.  Clinical hematology, chemistry and ECG monitoring indicated no emergent safety signals.

There were no drug-drug interactions identified in subjects who were utilizing a range of psychotropic and other concomitant medications.

"We are very pleased with the safety profile of NBI-98854 over twelve weeks of continuous dosing.  The drug was generally well tolerated and there were no obvious safety signals," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences.  "Although this phase of the Kinect study was not placebo-controlled, we are further encouraged by the reduction in tardive dyskinesia through Week 12."

Efficacy Profile

At Week 12, there was a marked reduction from baseline in the Abnormal Involuntary Movement Scale (AIMS) scores for both groups of subjects; those who were initially randomized to NBI-98854 with 12 weeks of continuous dosing and those who were originally randomized to placebo for 6 weeks, then entered the 6-week open-label extension of NBI-98854.  The Week 12 responder rate (defined as a 50% or greater reduction in AIMS from baseline) was 54%.

The Week 12 improvement in tardive dyskinesia symptoms was also corroborated by the Clinical Global Impression–Tardive Dyskinesia (CGI-TD). Treating clinicians determined at Week 12 that approximately
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SOURCE Neurocrine Biosciences, Inc.
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