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

IMS assessments. The primary efficacy endpoint of the study was a comparison of placebo and active scores as determined by the on-site AIMS raters at the end of Week 6.

Next Steps for NBI-98854

This Kinect twelve-week data, along with the initial six-week data from the Kinect study will be integrated with the Kinect 2 study data to inform the ultimate design of the next study.  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.

About Tardive Dyskinesia

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities: lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips, or involuntary movements of the limbs. These symptoms are rarely reversible and there is currently no approved treatment.

About NBI-98854

VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons.  NBI-98854, developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines, thereby reducing the likelihood of "off target" side effects.  NBI-98854 is designed to provide low, sustained, plasma and brain concentrations of active drug to minimize side effects associated with excessive monoamine depletion.  The Company has completed nine-month in-vivo toxicology studies to support longer dosing regimens in humans.

NBI-98854 may also be useful in other disorders such as Huntin
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SOURCE Neurocrine Biosciences, Inc.
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