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FDA Breakthrough Therapy Designation #54: Neurocrine Biosciences’ Product For Tardive Dyskinesia

October 31, 2014

Neurocrine Biosciences, a San Diego pharmaceutical company, announces on October 30th, that the FDA grants the company’s investigational product, NBI-98854, a Breakthrough Therapy Designation (BTD) for the treatment of Tardive Dyskinesia (TD). NBI-98854 is a Vesicular Monoamine Transporter 2 inhibitor. The FDA BTD is based on the data of a Phase IIb (KINECT study) that involved about 220 patients with TD.

Neurocrine Biosciences plans on a 1-year open-label safety study of NBI-98854 to support the anticipated 2016 filing of a New Drug Application with the FDA in TD. Also, the Company has initiated a Phase I (T-FORCE) clinical study assessing NBI-98854 in children and adolescents with Tourette syndrome.

People with TD exhibit involuntary, repetitive movements of the extremities – facial movements or blinking, involuntary movements of the limbs. TD is common in people with psychotic disorders who are treated with antipsychotic medications, especially dopamine antagonists for many years.

References

Neurocrine Biosciences’ Pipeline

FDA October 29, 2014 News Release

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Flickr – Nicholas T – Bows” by Nicholas A. Tonelli from Pennsylvania, USA (Bows) [CC-BY-2.0] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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