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Neurocrine Announces Phase II Results of VMAT2 Inhibitor NBI-98854 for Treatment of Tardive Dyskinesia
Date:3/26/2012

safety and tolerability profile," said Kevin C. Gorman President and Chief Executive Officer of Neurocrine Biosciences. "We will apply additional controls in future studies to ensure appropriate scoring of AIMS."

Trial DesignThis trial was a randomized, double-blind, placebo controlled, cross-over, Phase II clinical trial utilizing NBI-98854 in tardive dyskinesia patients at eight investigator sites. This 37 subject study assessed once-daily NBI-98854 (12.5mg and 50mg) over a two week dosing period. The primary endpoint of the study was a comparison of placebo vs. active scores utilizing the Abnormal Involuntary Movement Scale (AIMS).

Next Steps for NBI-98854A placebo controlled, double-blind, parallel design, multiple dose, twelve week Phase IIb study is planned to assess six-week dosing of NBI-98854 against placebo, followed by six weeks of active treatment with NBI-98854. The study will incorporate a capsule formulation of NBI-98854 and will be initiated in mid-2012, with top-line data anticipated by year-end.

About the Abnormal Involuntary Movement Scale (AIMS)The AIMS was developed in 1976 and has been used extensively in movement disorder assessments. It consists of distinct ratings of regional involuntary body movements that are observed during a structured neurological examination. Items one through seven rate facial, extremity and trunk movements; items eight through ten are overall global judgments of severity, incapacitation and patient awareness. All ten items are scored on a zero to four scale with zero being rated as none, and four being rated as severe. The primary endpoint is assessed on items one through seven.

About Tardive DyskinesiaTardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely r
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