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Neurocrine Announces Positive Results of VMAT2 Inhibitor NBI-98854 in Kinect 2 Study
Date:1/6/2014

nect 2 study randomized 102 subjects. At Week 6, the ITT population included 44 placebo subjects and 45 subjects who were randomized to NBI-98854. By Week 6, approximately 70% of the ITT population, randomized to NBI-98854, were titrated to the 75 mg dose, approximately 20% were titrated to the 50mg dose and the remaining subjects received 25 mg of NBI-98854. At Week 6 the PP population consisted of 44 placebo subjects and 34 subjects randomized to NBI-98854. The PP Week 6 final titrated dose level of NBI-98854 was similar to that of the ITT population. The PP population excluded eleven subjects whose plasma concentrations of NBI-98854 were below the lower limit of quantitation (i.e., not detectable). Given the timing of serum samples collections and the pharmacokinetic profile of NBI-98854, it was determined that these subjects had not ingested the study drug.  The subjects in the Kinect 2 study had moderate to severe tardive dyskinesia with a mean baseline video AIMS score of 8.0. Similar to previous studies, the average age of the trial participants was 56 years with an average age at onset of tardive dyskinesia of 49 years. Approximately 60% of the subjects were male.

Safety ProfileIn this study NBI-98854 was generally safe and well tolerated. During the six-week treatment period the frequency of treatment-emergent adverse events was 33% for placebo and 43% for NBI-98854. There were no drug related serious adverse events. The most common treatment emergent adverse events were fatigue in five subjects (9.8%) randomized to NBI-98854 vs. two subjects (4.1%) in the placebo group, and headache reported by four subjects (7.8%) on NBI-98854 vs. two subjects (4.1%) on placebo. Discontinuation rates were similar in both the NBI-98854 and placebo treatment groups with five per study arm (none of which were study drug related).

Participants were assessed utilizing the Barnes Akathisia Ratings Scale (BARS) for akathisia and the Simpson-Angus Scale (SAS) f
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SOURCE Neurocrine Biosciences, Inc.
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