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October 7, 2013
Neurocrine Biosciences reported results of a phase IIb study of NBI-98854 for the treatment of tardive dyskinesia. At week two, the randomized study included 109 subjects, including 54 placebo subjects and 27 and 26 subjects who were randomized to the 50mg and 100mg of NBI-98854, respectively. The average age of participants was 55 years and males made up approximately two-thirds of the subjects. All subjects were on stable doses of antipsychotic medication. The 50mg dose of NBI-98854 did not meet the primary endpoint in the phase IIb study, while the 100mg dose showed a statistical and clinically significant improvement. AIMS scores were reduced by 5.5 points in the 100mg per-protocol (PP) group compared to a reduction of 2.7 points in placebo (p=0.008), and the responder rate (>= 50% improvement from baseline) was 48% in the 100mg group compared to 23% in placebo (p=0.034). The 100mg dose was expected to be a maximum tolerated dose based on earlier data; however, in this patient population 100mg was well-tolerated.
April 11, 2011
Neurocrine Biosciences reported interim results from a phase IIa trial of NBI-98854 for Tardive Dyskinesia. This Canadian-based, open label, dose escalation trial plans to enroll up to ten subjects with schizophrenia and moderate to severe Tardive Dyskinesia. Data are from six subjects in the initial cohort. The subjects received three, four-day periods of NBI-98854 at increasing doses of 12.5mg, 25mg and 50mg administered once daily. After discontinuation of NBI-98854, a seven-day washout period was followed by a final assessment. The impact of NBI-98854 on the dyskinesia was assessed utilizing the Abnormal Involuntary Movement Scale (AIMS). In this initial cohort of six subjects, the mean baseline score was 14.3. After the twelve days of dosing, the mean AIMS score decreased to 8.4, a reduction of 41.3%. Reduction in abnormal involuntary movements was shown across multiple assessment points. After the seven-day washout period most of the AIMS scores returned to baseline levels.