The FDA has accepted for priority review a new drug application (NDA) for valbenazine (Ingrezza, Neurocrine Biosciences) for the treatment of patients with tardive dyskinesia (TD). The NDA has been given a target action date of April 11, 2017.
The application for valbenazine included results from the Kinect 2 and Kinect 3 trials, which evaluated more than 330 patients with TD, along with data from an additional 18 clinical studies.
Vesicular monoamine transporter 2 (VMAT2), a protein in the human brain, is primarily responsible for repackaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in presynaptic neurons. Valbenazine is an investigational, highly selective VMAT2 inhibitor that modulates dopamine release during nerve communication, showing little or no affinity for VMAT1 or other receptors, transporters, and ion channels.
Valbenazine is designed to provide low, sustained plasma and brain concentrations of active drug to allow once-daily dosing. The protein inhibitor received a breakthrough therapy designation from the FDA in 2014 for the treatment of patients with TD.
TD is characterized by involuntary, repetitive movements of the face, trunk, or extremities, including lip smacking, grimacing, tongue protrusion, facial movements, blinking, puckering, and pursing of the lips. These symptoms are rarely reversible, and there are no FDA-approved treatments.
Neurocrine Biosciences is also investigating the safety and efficacy of valbenazine in two phase 2 trials of subjects with Tourette syndrome (TS). Each of these studies is expected to enroll up to 90 subjects. In addition, the company recently launched an open-label, fixed-dose rollover study of valbenazine in up to 180 subjects with TS.
Source: Neurocrine Biosciences; October 11, 2016.