New Drug for Tardive Dyskinesia Demonstrates Efficacy in Phase 3 Study

Neurocrine Biosciences announced positive results from its Kinect 3 study, showing that NBI-98854 achieved a statistically significant reduction in tardive dyskinesia during the six weeks of treatment in patients with underlying schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder.

The Kinect 3 study is a randomized, parallel-group, double-blind, placebo-controlled, Phase 3 clinical trial utilizing the capsule formulation of NBI-98854 in patients with moderate to severe tardive dyskinesia. Patients were randomized to receive either NBI-98854 40mg once daily, NBI-98854 80mg once daily, or placebo for six weeks. The primary efficacy endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 in the 80mg dosing group compared to placebo as assessed by central blinded video raters.

Study results showed statistically significant reduction in tardive dyskinesia in both the 80mg and 40mg treatment groups. The AIMS rating at Week 6 for NBI-98854 80mg intention-to-treat (ITT) population was reduced 3.1 points (Least-Squares Mean) more than placebo (P<0.0001), meeting the primary efficacy endpoint. The AIMS rating at Week 6 for the 40mg dose was reduced 1.8 points more than placebo (P=0.0021).

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In addition to Kinect 3, Neurocrine has initiated Kinect 4, a separate one-year open-label safety study of NBI-98854 to support the anticipated 2016 filing of a New Drug Application in tardive dyskinesia. Neurocrine is also exploring NBI-98854 in open-label, multi-dose, two-week evaluation clinical study for Tourette syndrome.

NBI-98854 is a novel, highly-selective vesicular monoamine transporter 2 (VMAT2) inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines, thereby reducing the likelihood of side effects.

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