Press ReleaseNeurocrine Announces FDA Advisory Committee Meeting to Review INGREZZA™ (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia
The NDA for INGREZZA 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 Committee is an independent panel of experts that reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields and makes appropriate recommendations to the
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive movements of the face, trunk, or extremities, including lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips. 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. INGREZZA (valbenazine or 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. INGREZZA 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, may provide symptomatic benefits for patients with these diseases.
Neurocrine received Breakthrough Therapy Designation from the
The Company is also investigating the safety and efficacy of INGREZZA in the treatment of Tourette syndrome. The Company has two ongoing placebo-controlled Phase II Tourette syndrome studies evaluating INGREZZA 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 INGREZZA 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 INGREZZA development. Specifically, the risks and uncertainties the Company faces include risks that the INGREZZA NDA may not obtain regulatory approval from the
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Contact at Neurocrine Biosciences, Investor Relations, (858) 617-7600