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

61% of the subjects taking NBI-98854 were "much improved" or "very much improved" at Week 12.  The twelve-week treatment period was followed by a four-week washout period.  At the end of this washout period, only 29% of these same subjects were evaluated by the treating physicians as "much improved" or "very much improved" utilizing the CGI-TD.

"This twelve-week safety and related efficacy data is another important component for our End of Phase II FDA meeting that we plan to request during the first half of 2014," said Kevin C. Gorman, Chief Executive Officer of Neurocrine Biosciences.

Subject Profile

The Kinect study randomized 109 subjects; 81 subjects completed Week 12, of which 42  subjects were originally randomized to placebo and 39 were originally randomized to NBI-98854.  Similar to the Company's other studies, the average age of the trial participants was 55 years with an average age at onset of tardive dyskinesia of 47 years.  Approximately two-thirds of the subjects were male.

Kinect Study Design

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 two doses of once-daily NBI-98854 over a six-week placebo-controlled dosing period.  Half of the randomized subjects received placebo and half received one of two doses of NBI-98854.  The two NBI-98854 dosing groups consisted of a 50mg group for six weeks and a group that began at 100mg for the initial two weeks then converted to 50mg for the final four weeks of the placebo-controlled dosing period.  Subsequent to the placebo-controlled dosing, all subjects were eligible to enter a six-week open-label safety extension of 50mg of NBI-98854 administered once daily with additional A
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SOURCE Neurocrine Biosciences, Inc.
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