Neurocrine's NBI-98854 misses in tardive dyskinesia trial

Neurocrine Biosciences Inc. (NASDAQ:NBIX) said once-daily 50 mg oral NBI-98854 missed the primary endpoint in 99 patients in the intent-to-treat (ITT) population of the Phase IIb Kinect Study to treat tardive dyskinesia. NBI-98854 did not reduce mean Abnormal Involuntary Movements Scale (AIMS) score from baseline to week six vs. placebo as determined by either onsite or blinded central video assessment.

The trial enrolled patients with moderate to severe tardive dyskinesia and underlying schizophrenia or schizoaffective disorder to receive 50 mg NBI-98854 for six weeks; 100 mg NBI-98854 for two weeks followed by 50 mg NBI-98854 for four weeks; or placebo. At week two, the once-daily 100 mg dose of NBI-98854 significantly reduced mean AIMS scores from baseline vs. placebo as determined by blinded central video assessment (4.8 vs. 2.7 points, p=0.034). ...