New data on Ingrezza (valbenazine) adds to the growing body of evidence demonstrating functional and quality of life improvements in patients with tardive dyskinesia - Neurocrine Biosciences

Neurocrine Biosciences, Inc. announced the presentation of new analyses from a Phase IV randomized withdrawal study (NCT03891862) showing patients with tardive dyskinesia who received continued treatment with Ingrezza (valbenazine) capsules reported improvements across functional and health-related quality of life measures. These findings complement recently announced patient-reported outcome data from the Phase IV KINECT-PRO study of Ingrezza, which was the first of its kind to specifically measure and report clinically meaningful improvements in the impact of tardive dyskinesia. The analyses were presented at the 2025 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conference in Montreal, Canada.

"Tardive dyskinesia can affect patients' daily lives, causing pain and anxiety and hindering the ability to perform self-care tasks and to participate in work, family or social life," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "These unique analyses add to the expansive body of evidence demonstrating that Ingrezza treatment can significantly improve tardive dyskinesia patients' quality of life, addressing outcomes important to both patients and healthcare providers."

The analyses were conducted using data from 127 patients who participated in a Phase IV, double-blind, placebo-controlled, randomized withdrawal study. Patients received up to 80 mg of Ingrezza for eight weeks, after which they were randomized to either continue Ingrezza (n=59) or receive placebo (n=59) for an additional eight weeks.

1. Health-related quality of life (HRQoL) was measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L), which includes five dimensions of health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). A utility index, ranging from -0.573 to 1.0, and visual analog scale (EQ-VAS), ranging from 0 to 100, were also reported with higher scores indicating better health status.

2. Functional impairment was measured using the five-item Sheehan Disability Scale (SDS), in which three items assessed work/school (patient had to be working or attending school to be included), social life and family/home life impairment. Scores were combined for an SDS total score for patients with work/school scores. Reductions in scores indicated improvement.

In the open-label portion of the study, patients receiving Ingrezza treatment for eight weeks experienced significant improvements from baseline in multiple areas of HRQoL (Poster #PCR191), including mobility (change from baseline: -0.27), self-care (-0.28), usual activities (-0.36) and pain/discomfort (-0.34). Those randomized to receive Ingrezza for an additional eight weeks (Week 16) saw continued improvements in all HRQoL dimensions, including significant improvements in mobility (placebo-adjusted difference from Week 8: -0.34) and anxiety/depression (-0.38) compared with those receiving placebo.

In a separate analysis, patients in the open-label portion of the same study receiving Ingrezza treatment for eight weeks experienced significant improvements from baseline in work/school (change from baseline: -1.37), social life (-1.65), family/home life (-1.30) and SDS total score (-4.28). Those randomized to receive Ingrezza for an additional eight weeks saw continued improvements in all domains, including significant improvements in social life (placebo-adjusted difference from Week 8: -0.95) and family/home life (-0.89) compared with those receiving placebo.

The KINECT-PRO Phase IV, open-label study was designed to evaluate patient reported outcomes on the use of Ingrezza (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of Ingrezza once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT-3 and KINECT-4 studies.