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

 

p=0.59

p=0.42Responder Analysis 

 

 

 "Much Improved or Very Much Improved" 

 

 

   Clinical Global Impression-Tardive Dyskinesia

n/a

52%

65%

60%  Patient Global Impression of Change

n/a

39%

53%

60%  Excluding Single Site Baseline(mean)Placebo12.5mg50mgAbnormal Involuntary Movement Scale (LS Means)14.9

10.3

9.9

6.1 

 

 

p=0.68

p=0.002Responder Analysis end of Treatment 

 

 

 "Much Improved or Very Much Improved" 

 

 

 Clinical Global Impression-Tardive Dyskinesia

n/a

46%

67%

80%Patient Global Impression of Change

n/a

38%

62%

80%Safety ProfileNBI-98854 was generally safe and well tolerated; the frequency of treatment-emergent adverse events was 17% during the placebo period and 24% and 32% in the 12.5mg and 50mg treatment periods, respectively. There were no serious adverse events during the treatment period. The most common adverse event was headache and one subject in the 50mg group discontinued due to akathisia. The underlying psychiatric state of subjects was monitored using the Brief Psychiatric Ratings Scale (BPRS) and shown to be stable or improved across study groups declining from 32 at baseline to 28 at the end of the study. There were no drug-drug interactions identified in subjects who were utilizing a range of psychotropic and other concomitant medications.

"While not ideal, this study served its primary purpose of informing the larger Phase IIb studies. The 50mg once-daily dose of NBI-98854 provided tardive dyskinesia sufferers with a remarkable improvement of symptoms, coupled with an excellent
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SOURCE Neurocrine Biosciences, Inc.
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