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

SAN DIEGO, Jan. 9, 2014 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that NBI-98854, a small molecule VMAT2 inhibitor, in development for tardive dyskinesia, showed an excellent safety profile and a clinically meaningful reduction in tardive dyskinesia symptoms in up to twelve weeks of continuous dosing. This is the second study reporting out this week that demonstrates the potential of NBI-98854 as a safe and highly effective therapy for tardive dyskinesia sufferers. Both of these studies will serve as the foundation for an End of Phase II meeting later this year.

The Kinect study was a randomized, parallel, double-blind, placebo-controlled, Phase IIb clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia or schizoaffective disorder.  The study assessed NBI-98854 over a six-week placebo-controlled dosing period.  The top-line results from the placebo-controlled portion were previously reported by the Company in September 2013.  Subsequent to the placebo-controlled dosing period, all subjects were eligible to enter a six-week open-label safety extension of 50 mg of NBI-98854 administered once daily, followed by a four-week washout period.

NBI-98854 was generally safe and well tolerated in the Kinect study.  During the twelve-week treatment period the frequency of treatment-emergent adverse events was 40% for NBI-98854, similar to previous clinical trials.  There were no drug related serious adverse events.  The most common treatment-emergent adverse event during the entire twelve-week period was urinary tract infection in six subjects (5.9%) on NBI-98854, which were assessed as not related to study drug by the investigators.  All other adverse events occurred at less than a 3% f
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SOURCE Neurocrine Biosciences, Inc.
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