Neurocrine Biosciences, Inc. has submitted a New Drug Application (NDA) to the US 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 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 FDA for valbenazine in the treatment of tardive dyskinesia.

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.

Neurocrine Biosciences, Inc. discovers and develops innovative and life-changing pharmaceuticals, in diseases with high unmet medical needs, through its novel R&D platform, focused on neurological and endocrine based diseases and disorders.