in early July 2013. The study is a placebo-controlled, double-blind, parallel-design, multiple-dose, 12-week study assessing six-week dosing of NBI-98854 against placebo, followed by six weeks of open-label treatment with NBI-98854 in tardive dyskinesia patients with underlying schizophrenia or schizoaffective disorder. The primary endpoint is the Abnormal Involuntary Movement Scale (AIMS) at the end of the first six weeks of dosing. The study has incorporated a capsule formulation of NBI-98854. Top-line data from the placebo-controlled portion of this study is expected in September 2013.
The Kinect 2 Study is a 90 subject, placebo-controlled, double-blind, parallel-design, multiple-dose, six-week study assessing NBI-98854 against placebo in tardive dyskinesia patients with underlying mood disorders, schizophrenia and schizoaffective disorders, and gastrointestinal disorders. The primary endpoint is the AIMS at the end of the six weeks of dosing. This study continues to enroll patients, and top-line data from this study is expected in the fourth quarter of 2013.
The Company plans to request an end of Phase II meeting with the FDA for NBI-98854 in tardive dyskinesia during the fourth quarter of 2013.
The Company is also in the process of initiating two Phase I studies for NBI-98854 assessing drug-drug interactions as well as the impact of hepatic impairment on drug metabolism. Both of these studies will be completed prior to the start of Phase III and will support the planned NDA filing.
Additionally, the Company has initiated preclinical studies to support the advancement of NBI-98854 into clinical trials for individuals suffering from Tourette's syndrome. Upon successful completion of these preclinical studies, the Company anticipates entering Phase I and Phase II clinical studies in 2014.
Conference Call and Webcast Today at 5:00PM Eastern Time
Neurocrine will hold a live conference call and webcast today at 5:00 p.m. Easter
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