Positive results have been reported from a phase 3 study of valbenazine (Ingrezza, Neurocrine Biosciences), a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, for the treatment of patients with tardive dyskinesia. Once-daily valbenazine demonstrated a significant reduction in TD symptoms compared with placebo in participants with underlying schizophrenia, schizoaffective disorder, or mood disorder. The findings were published online in the American Journal of Psychiatry.
Neurocrine Biosciences has submitted a new drug application to the FDA for valbenazine and has been granted a priority review, with a Prescription Drug User Fee Act (PDUFA) action date of April 11, 2017. Neurocrine also received a breakthrough therapy designation from the FDA in 2014 for valbenazine for the treatment of patients with TD.