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

or parkinsonism. Both of these scales documented minimal symptoms at baseline and there was no worsening during the six weeks of treatment. 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.

Next Steps for NBI-98854Data from the Kinect 2 study will be integrated with the Kinect study data to inform the ultimate design of the next study, Kinect 3. The Company will work with its consultants and scientific advisors to expand and refine the pharmacokinetic/pharmacodynamic models as well as to complete the remaining safety and efficacy analyses from both Kinect and Kinect 2. These data will form the basis for an End of Phase II briefing package along with the proposed Phase III protocol.

Kinect 2 Study DesignThe Kinect 2 Study was a randomized, parallel, double-blind, placebo-controlled, dose titration Phase IIb clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with an underlying mood disorder (e.g., bipolar disorder), schizophrenia or schizoaffective disorder, or a gastrointestinal disorder with exposure to metoclopramide. This 100 subject study assessed once-daily NBI-98854 over a six-week placebo-controlled dosing period. Half of the randomized subjects received placebo and half received NBI-98854. The NBI-98854 dosing regimen began with a once-daily dose of 25 mg for the initial two weeks. At the completion of the initial two weeks of dosing, based on certain efficacy and safety criteria, patients were titrated to a once-daily 50 mg dose, or continued on the once-daily 25 mg dose for the following two-week period. At the completion of the second two weeks of treatment another efficacy and safety assessment was performed and patients were eligible to be titrated to a once-daily 75 mg, 50 mg or 25 mg dose for the
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SOURCE Neurocrine Biosciences, Inc.
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