Press ReleaseNeurocrine Submits New Drug Application for Valbenazine for Treatment of 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
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
About Tardive Dyskinesia
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
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 that modulates dopamine release during nerve communication, showing little or no affinity for VMAT1, other receptors, transporters and ion channels. Valbenazine is designed to provide low, sustained, plasma and brain concentrations of active drug to allow for once daily dosing.
Modulation of neuronal dopamine levels in diseases such as tardive dyskinesia, Tourette syndrome, Huntington's chorea, schizophrenia, and tardive dystonia, which are characterized, in part, by a hyperdopaminergic state, should provide symptomatic benefits for patients with these diseases.
Neurocrine has received Breakthrough Therapy Designation from the
The Company is also investigating the safety and efficacy of valbenazine in the treatment of Tourette syndrome. The Company has two ongoing placebo-controlled Phase II Tourette syndrome studies evaluating valbenazine in adults and pediatrics, the T-Forward study and T-Force GREEN study, respectively. Each of these studies is expected to enroll up to 90 subjects with Tourette syndrome. Additionally, the Company has recently launched an open-label, fixed-dose rollover study of valbenazine in up to 180 subjects with Tourette syndrome.
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's business and finances in general, as well as risks and uncertainties associated with valbenazine development. Specifically, the risks and uncertainties the Company faces include risks that the valbenazine NDA may not be accepted for filing by the
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Neurocrine Biosciences, Investor Relations, (858) 617-7600