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Neurocrine Submits New Drug Application for Valbenazine for Treatment of Tardive Dyskinesia

SAN DIEGO, Aug. 29, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-daily dosing of valbenazine in treating tardive dyskinesia.

"This is an important milestone in the development of valbenazine for the treatment of tardive dyskinesia, a serious disease for which there is no FDA approved pharmaceutical treatment," said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "We look forward to working with the FDA in their review of the valbenazine NDA submission to potentially bring this important treatment option to patients and physicians."

The NDA for valbenazine includes the results from the Kinect 2 and Kinect 3 clinical trials which evaluated over 330 tardive dyskinesia patients. Data from these studies along with the results from another 18 clinical trials, extensive preclinical testing and drug manufacturing data were included in the NDA submission. The Company expects to receive notification of the acceptance of the NDA, as well as the timeframe for NDA review from the FDA in October 2016.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the face: lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips, or the extremities. These symptoms are rarely reversible and there are currently no FDA approved treatments.

VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons. Valbenazine (NBI-98854), developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor...


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