Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new analyses from a Phase 4 randomized withdrawal study demonstrating significant patient-reported improvements in health-related quality of life and functional measures among adults aged 65 years and older with tardive dyskinesia who received continued treatment with INGREZZA® (valbenazine) capsules. Findings will be presented at the 2025 American Association of Nurse Practitioners National Conference in San Diego. These post-hoc analyses of older adults expand on recently announced Phase 4 study results, which demonstrated that continued treatment with INGREZZA improved functional status and quality of life measures across the general patient population.
“Older adults are not only at increased risk for developing tardive dyskinesia, but are also more susceptible to the profound physical, functional and social consequences of their uncontrolled movements,” said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. “These new post-hoc analyses demonstrate that INGREZZA can provide significant and persistent improvements in quality of life for older adults with tardive dyskinesia and are consistent with the unique and substantial body of evidence that INGREZZA treatment can provide robust improvement in outcomes beyond tardive dyskinesia severity.”
The analyses were conducted in a subset of 29 adult patients (≥65 years) who participated in a Phase 4, double-blind, placebo-controlled, randomized withdrawal study (NCT03891862). During an initial eight-week, open-label period, all patients received up to 80 mg of INGREZZA daily. At Week 8 (randomization baseline), patients were randomized to either continue INGREZZA (n=13) or switch to placebo (n=16) for an additional eight weeks. Analyses were conducted for patients who had available data during the double-blind period from Week 8 to Week 16.
Patients who received continued treatment with INGREZZA reported significant improvements in health-related quality of life and functional status, compared with those randomized to placebo. Two clinically validated scales were used to assess patient-reported outcomes, providing a comprehensive and scientifically robust measure of health status:
- The EuroQol 5-Dimension 5-Level (EQ-5D-5L) assessment tool, which measures health-related quality of life across five dimensions of health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
- The Sheehan Disability Scale (SDS), which measures patient-reported functional impairment in work/school, social life and family/home life impairment.
These analyses contribute to the growing body of evidence for INGREZZA use in older adults (>65 years). A recently published post-hoc analysis from two 48-week studies, the KINECT® 3 extension and KINECT® 4, demonstrated the long-term safety profile and robust efficacy of INGREZZA in adults aged 65 years and older with tardive dyskinesia (TD). In addition, the analyses further reinforce findings from the KINECT-PRO™ study of INGREZZA – a first-of-its-kind study that demonstrated clinically meaningful improvement in patient-reported impact of TD with a vesicular monoamine transporter 2 inhibitor and used multiple clinically validated, patient-reported scales.
Additional presentations at the 2025 AANP National Conference include:
- Real-World Insights on Tardive Dyskinesia: A Claims-Based Analysis of Demographics and Healthcare Resource Utilization (Poster #24)
- Clinically Meaningful Long-Term Improvements with Valbenazine 40 mg in Adults with Tardive Dyskinesia (Poster #25)
