Phase III trial of Ingrezza shows drug well tolerated in tardive dyskinesia

Neurocrine Biosciences announced that new long-term data from the KINECT 4 Phase III open-label study demonstrate that once-daily INGREZZA (valbenazine) capsules, the first FDA approved treatment for adults with tardive dyskinesia (TD), improved TD symptoms through 48 weeks of open-label treatment and was generally well tolerated.

In addition to the KINECT 4 Phase III study results, Neurocrine also presented pooled data analyses from three double-blind, placebo-controlled INGREZZA studies (KINECT, KINECT 2 and KINECT 3) across patient sub-groups (219 participants in the above 55 years of age subgroup and 154 participants in the less than 55 years of age subgroup). Pooled data analyses showed that once-daily INGREZZA improved tardive dyskinesia symptoms and was generally well tolerated in both older and younger adults. These data were presented at the American College of Neuropsychopharmacology (ACNP) Annual Meeting.