Neurocrine Announces Phase II Results of VMAT2 Inhibitor NBI-98854 for Treatment of Tardive Dyskinesia

Neurocrine Biosciences, Inc. NBIX today announced efficacy and safety results from a Phase II trial of NBI-98854 in 37 tardive dyskinesia patients. For the final analysis, data from one site was removed due to the inconsistent and incorrect application of the efficacy assessment protocol. With this site removed, the results showed a significant reduction in tardive dyskinesia symptoms at end of two weeks of active treatment with 50mg once-daily doses of NBI-98854. "This Phase II trial was extremely informative. NBI-98854 displayed the efficacy and safety data we expected to see in both the 12.5mg and 50mg doses," said Chris O'Brien, Chief Medical Officer of Neurocrine Biosciences. "While we had data inconsistencies at one site, this study has provided us with the necessary information and confidence to move forward into the larger Phase IIb trials as planned." After database lock and unblinding of study data, the pre-specified statistical assessment was conducted and the normal quality control evaluation of the output performed. An inconsistent pattern of Abnormal Involuntary Movement Scale (AIMS) scores emerged at one of the eight sites that was not evident during the blinded data review. Potential errors in randomization and drug exposure as causes for this data inconsistency were ruled out. However, a review of videotaped AIMS assessments at this single site noted discrepancies between the clinical score and the video record which were well outside of the variability associated with the AIMS. Additionally, videotaped AIMS assessments were reviewed at other sites and found to be administered appropriately.