Ingrezza Treatment Associated with Sustained Improvements in Patients with Tardive Dyskinesia

Results of a post hoc analysis of the KINECT-4 study showed that the majority of participants with tardive dyskinesia (TD) who completed 48 weeks of once-daily Ingrezza (valbenazine; Neurocrine Biosciences, San Diego, CA) treatment experienced clinically meaningful and sustained TD improvements. These results, published in the Journal of Clinical Psychopharmacology, demonstrate the long-term efficacy of Ingrezza for the treatment of TD.

Post hoc analysis of the open-label, phase 3 KINECT-4 study (NCT02405091) included individuals with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder who received Ingrezza (40 or 80 mg) once-daily for 48 weeks, followed by a 4-week washout. Study site investigators or other trained and qualified individuals evaluated Ingrezza treatment in participants who completed the study (n=103) using the Abnormal Involuntary Movement Scale (AIMS), Clinical Global Impression of Change—TD (CGI-TD) scale, and Patient Global Impression of Change (PGIC) scale.

• 55% of participants experienced clinically meaningful improvement (defined as ≥2-point reduction in AIMS total score) by week 4, and this increased to 97% of participants at week 48.
• 86% of participants experienced ≥50% improvements in AIMS scores, and TD improvement was sustained throughout treatment, with an AIMS mean total score reduction from baseline to week 48 of 10.5.
• At week 48, over 88% of participants achieved CGI-TD and PGIC ratings of "much improved" or "very much improved."

"TD is a persistent, debilitating disorder requiring continuous treatment to effectively and sustainably improve symptoms over time," said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. "This post hoc analysis, along with previous long-term analyses, demonstrate the reliable, long-term efficacy and tolerability of one-capsule, once-daily Ingrezza to help inform use of this treatment in clinical practice."