Mood Disorders

January 20, 2014

Neurocrine Biosciences issued results of a phase IIb study of NBI-98854. The randomized, parallel, double-blind, placebo-controlled, dose-titration trial utilized the capsule formulation in moderate to severe tardive dyskinesia patients with an underlying mood 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. The dosing regimen began with a once-daily dose of 25mg for the initial two weeks before patients were titrated to a once-daily 50mg dose, or continued on the once-daily 25mg dose for the following two-week period. At the completion of the second two weeks of treatment, patients were eligible to be titrated to a once-daily 75mg, 50mg or 25mg dose for the final two weeks of treatment. At week 6, the Abnormal Involuntary Movement Scale (AIMS) scores were reduced by 2.6 points in the NBI-98854 intention-to-treat (ITT) group compared to a reduction of 0.2 points in the placebo arm (p<0.001). Additionally, the responder rate (>= 50% improvement from baseline) was 49% in the NBI-98854 ITT group compared to 18% in placebo (p=0.002). In the per-protocol (PP) group AIMS scores were reduced by 3.3 points for those subjects taking NBI-98854 (p<0.001), with a corresponding responder rate of 59% (p<0.001).

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