Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name "INGREZZA™" for the Company's once-daily vesicular monoamine transporter 2 (VMAT2) inhibitor valbenazine. The Company has recently announced the submission of a New Drug Application (NDA) with the FDA for valbenazine in tardive dyskinesia and is also exploring its utility in Tourette syndrome.
The name INGREZZA (pronounced in-GREH-zah) was developed using the FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names consistent with the goal of preventing medication errors. Additionally, the proprietary name development program included prescribers, pharmacists and linguists to create a unique, memorable name that helps to connote the clinical value of INGREZZA.
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 filing. The Company expects to receive notification of the acceptance of the NDA filing, as well as the timeframe for NDA review from the FDA in October 2016.
