The first and only study to measure patient-reported TD impact using multiple validated scales
Data on file. Neurocrine Biosciences, Inc.
Efficacy in adults with tardive dyskinesia
SELECT EFFICACY ENDPOINT:
6-week reductions
48-week reductions
Long-term remission
6-week reductions
6-week reductions
48-week reductions
Long-term remission
Rapid, robust results. Consistently achieved1-3
Reduction in AIMS total score1-3
Mean baseline AIMS scores:
Placebo 9.9, 40 mg 9.8, 80 mg 10.4
Primary endpoint was analyzed using an MMRM based on ITT population.
An effect size of 0.2 is considered small, 0.5 is medium, and 0.8 is large.
aP≤0.001 vs placebo; adjusted for multiplicity.
AIMS, Abnormal Involuntary Movement Scale; BL, baseline; ITT, intent-to-treat; LS mean, least squares mean; MMRM, mixed model for repeated measures.
KINECT 3 STUDY DESIGN
Reductions that lasted long-term4,5
Reduction in AIMS total score in an open-label study (scores from site raters)4,5,*
Patients in KINECT 4 followed a different dosing schedule than KINECT 3 pivotal study. See “KINECT 4 STUDY DESIGN” for additional detail.
*Data not shown for 11 patients who had a dose reduction from 80 mg to 40 mg after Week 4.
BL, baseline.
KINECT 4 STUDY DESIGN
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Patients achieved symptomatic remission in 2 distinct studies4,6
As measured by a score of 0 (“none”) or 1 (“minimal”) on each AIMS item 1-74,6
Post hoc analyses of KINECT 4 and KINECT-PRO completers taking INGREZZA who followed a different schedule than KINECT 3. Results are descriptive.
KINECT-PRO is a phase 4, open-label, 24-week interventional study.
BL, baseline.
UNDERSTANDING REMISSION IN TD
KINECT 4 STUDY DESIGN
Post hoc analyses of KINECT 4 and KINECT-PRO completers taking INGREZZA who followed a different schedule than KINECT 3. Results are descriptive.
KINECT-PRO is a phase 4, open-label, 24-week interventional study.
BL, baseline.
DOWNLOAD THE REPRINTS FOR MORE RESULTS FROM KINECT 4
SEE EFFICACY IN ELDERLY PATIENTS WITH TD (AGE 65+)
Patients saw sustained reductions in TD severity, regardless of dosage4,7,8
DATA FROM 3 6-WEEK, CONTROLLED STUDIES (KINECT, KINECT 2, KINECT 3) AND 2 LONG-TERM STUDIES (KINECT 3, KINECT 4)
Change from baseline in AIMS dyskinesia total score through 48 weeks4,7,8
Post hoc analysis from 3 6-week, controlled studies (KINECT, KINECT 2, KINECT 3) and 2 long-term studies (KINECT 3, KINECT 4). Outcomes analyzed at Week 6 in the pooled double-blind, placebo-controlled population and at Week 48 in the pooled long-term population (central video raters for KINECT 3 and site raters for KINECT 4). Least squares (LS) mean presented for Week 5; mean presented for Week 49. Week 6 mean change was similar to LS mean; Cohen’s d calculated from LS mean.
Results are descriptive.
b40 mg data includes doses of 40 mg and 50 mg; 80 mg data includes doses of 75 mg and 60 mg.
DOWNLOAD THE REPRINT TO LEARN MORE ABOUT INGREZZA® (valbenazine) CAPSULES DATA IN ELDERLY PATIENTS
POST HOC ANALYSIS IN ELDERLY (AGE 65+)Watch expert perspective videos on INGREZZA® (valbenazine) capsules
Featuring Amy LaCouture, RN, BSN, PMHNP-BC
These videos were sponsored and developed by Neurocrine Biosciences.
The speaker is a paid consultant of Neurocrine Biosciences.
Why I choose INGREZZA for my adult patients with tardive dyskinesia (TD)
Case study: John, a patient with schizophrenia and tardive dyskinesia (TD)
PATIENT-REPORTED OUTCOMES WITH
INGREZZA
The first and only patient-reported outcome designed for and validated in TD patients4
REVIEW PRO DATASEE REAL-WORLD
RESULTS
WITH INGREZZA
View videos of real-world patients with TD treated with INGREZZA
WATCH CASE VIDEOS
INGREZZA CLINICAL
SAFETY DATA
INGREZZA was studied across a broad range of TD patients
VIEW SAFETY PROFILEREFERENCES:
- INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc.
- Nguyen HQ, Kuan HS, Crass RL, et al. A model-informed drug development approach supporting the approval of an unstudied valbenazine dose for patients with tardive dyskinesia. J Clin Pharmacol. 2024;64(11):1456-1465.
- Hauser RA, Factor SA, Marder SR, et al. KINECT 3: a phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J Psychiatry. 2017;174(5):476-484.
- Data on file. Neurocrine Biosciences, Inc.
- Marder SR, Singer C, Lindenmayer JP, et al. A phase 3, 1-year, open-label trial of valbenazine in adults with tardive dyskinesia. J Clin Psychopharmacol. 2019;39(6):620-627.
- Correll CU, Citrome L, Singer C, et al. Sustained treatment response and global improvements with long-term valbenazine in patients with tardive dyskinesia. J Clin Psychopharmacol. 2024;44(4):353-361.
- Sajatovic M, Alexopoulos GS, Jen E, Farahmand K, Zinger C. Improvements over time with valbenazine in elderly adults (≥65 years) with tardive dyskinesia: post hoc analyses of two long-term studies. J Clin Psychiatry. 2025;86(2):24m15550.
- Factor SA, Remington G, Comella CL, et al. The effects of valbenazine in participants with tardive dyskinesia: Results of the 1-year KINECT 3 extension study. J Clin Psychiatry. 2017;78(9):1344-1350.
