Neurocrine Biosciences announced that the FDA has granted Breakthrough Therapy designation for NBI-98854, its vesicular monoamine transporter 2 inhibitor, for tardive dyskinesia. NBI-98854 is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines.

The Breakthrough Therapy designation was granted partly based on results of the Phase 2b Kinect studies with NBI-98854 in approximately 220 patients with tardive dyskinesia.

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In addition to the tardive dyskinesia indication, a clinical study assessing NBI-98854 in children and adolescents with Tourette syndrome has been initiated recently. The company plans to initiate a one-year open-label safety study with NBI-98854 to support the anticipated 2016 filing of a New Drug Application (NDA) to the FDA in tardive dyskinesia.

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