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

ant improvement in tardive dyskinesia symptoms for the subjects while receiving the 50mg once-daily dose. These subjects had a significant reduction in tardive dyskinesia symptoms at the end of two weeks of active treatment vs. the end of two weeks of placebo (difference in LS mean of 4.2 for the 50mg period vs. the placebo period, p-value=0.002). As expected, the 12.5mg dosing group was not statistically better during the active treatment period than during the placebo period (difference in LS mean of 0.4 for the 12.5mg period vs. placebo period, p-value=0.68).

The improvement in symptomology is also evidenced by the significant improvement in AIMS scores over baseline levels relative to placebo, excluding the one site. NBI-98854 reduced the average baseline AIMS score by 9.2 points in the 50mg period (p-value=0.0004) vs. a reduction of 4.9 points in the 12.5mg period and 4.7 for the placebo periods. A responder analysis also showed improvement in both the investigator reported Clinical Global Impression-Tardive Dyskinesia and the patient reported Patient Global Impression of Change.

When including the data from the site in question, this study did not meet the pre-specified primary endpoint of reducing the AIMS scores during active treatment periods. The efficacy results from the entire study population showed a non-significant reduction in tardive dyskinesia at the end of two weeks of active treatment vs. the end of two weeks of placebo (difference in LS mean of 1.1 for the 50mg period vs. the placebo period (n=15), p-value=0.42) (difference in LS mean of 0.7 for the 12.5mg period vs. placebo period (n=17), p-value=0.59).

The tables below summarize the primary endpoint as well as the responder analyses for all clinical sites as well as the post-hoc analysis. All Clinical Trial Sites Baseline(mean)Placebo12.5mg50mgAbnormal Involuntary Movement Scale (LS Means)14.7

9.9

9.1

8.8 

 


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SOURCE Neurocrine Biosciences, Inc.
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