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INGREZZA® (valbenazine) capsules for adults with tardive dyskinesia (TD) Home Logo

Efficacy in adults with tardive dyskinesia

SELECT EFFICACY ENDPOINT:

6-week reductions

48-week reductions

48-week response

Long-term remission

6-week reductions

6-week reductions

48-week reductions

48-week response

Long-term remission

Rapid, robust results. Simply achieved.1-3

REDUCTIONS IN AIMS TOTAL SCORE IN KINECT 3

Mean change in AIMS total score from baseline to Week 61-3

Mean change in AIMS total score from baseline to Week 6
Mean change in AIMS total score from baseline to Week 6

Mean baseline AIMS scores:

Placebo 9.9, 40 mg 9.8, 80 mg 10.4

Greater than ten times reduction AIMS total score versus placebo, with every dose. See footnotes one and three.

aP≤0.001 vs placebo; adjusted for multiplicity.

Effect size=0.9.

*Based on modeling and simulation. The LS mean is adjusted for baseline AIMS score and disease category and is shown for consistency with 40 mg and 80 mg observed values from the KINECT 3 study.

AIMS, Abnormal Involuntary Movement Scale; BL, baseline; ITT, intent-to-treat; LS mean, least squares mean; SD, standard deviation; SEM, standard error of mean.

KINECT 3 STUDY DESIGN

Sustained reductions. Sustained satisfaction.4-6

REDUCTIONS IN AIMS TOTAL SCORE IN OPEN-LABEL KINECT 4

Mean change in AIMS total score from baseline to Week 48 (site raters)4,5*

LS mean change in AIMS from BL over 48-weeks Reference: number of patients, and dosage over time.
LS mean change in AIMS from BL over 48-weeks

Mean baseline AIMS scores: 40 mg 14.2, 80 mg 15.0

Even at the lowest dose, greater than ten point reduction in AIMS score at forty-eight weeks

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.

Over ninety-eight percent patients satisfied with their treatment

†(n/N=55/56). In rollover study of patients who completed KINECT 3 and KINECT 4 studies. Analysis at baseline and for completers of rollover study.

KINECT 4 STUDY DESIGN

DOWNLOAD THE REPRINTS FOR MORE RESULTS FROM KINECT 4

Clinically meaningful improvements—early and over time7

TREATMENT RESPONSE IN OPEN-LABEL KINECT 4

MCID in AIMS total score through Week 48 (completers; n/N=103/167)7

MCID in AIMS total score through week 48
MCID in AIMS total score through week 48
Ninety seven percent of completers achieved clinically meaningful improvements with Ingrezza at week forty eight.

Minimal clinically important difference (MCID) established by the TD Working Group of key opinion leaders in psychiatry and neurology.8

A ≥2-point decrease in AIMS corresponds to symptoms reported “minimally to very much improved” on Patient Global Impression of Change and Clinical Global Impression of Change scales.8

Post hoc analysis of KINECT 4 completers taking INGREZZA (40 mg and 80 mg). Results are descriptive.

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.

KINECT 4 STUDY DESIGN

DOWNLOAD THE REPRINTS FOR MORE RESULTS FROM KINECT 4

More than reductions. Achieve remission with INGREZZA.4,7,8

TD REMISSION IN OPEN-LABEL KINECT 4

Patients with ≤1 on each AIMS item 1‍–‍7 at Week 484,7,8

Percent of TD patients in Remission, Baseline vs Week 48

Patients in KINECT 4 followed a different dosing schedule than KINECT 3 pivotal study. See “KINECT 4 STUDY DESIGN” for additional detail.

Remission Scores

UNDERSTANDING REMISSION IN TD

KINECT 4 STUDY DESIGN

Post hoc analysis of KINECT 4 completers taking INGREZZA (40 mg and 80 mg).

Results are descriptive.

Remission defined as "complete response" by study authors.

Patients in KINECT 4 followed a different dosing schedule than KINECT 3 pivotal study. See “KINECT 4 STUDY DESIGN” for additional detail.

DOWNLOAD THE REPRINTS FOR MORE RESULTS FROM KINECT 4

Watch expert perspective videos on INGREZZA

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)

Why I choose INGREZZA for my adult patients with tardive dyskinesia (TD), video

Case study: John, a patient with schizophrenia and tardive dyskinesia (TD)

Case study: John, a patient with schizophrenia and tardive dyskinesia (TD), video

THERAPEUTIC DOSE FROM DAY 1

The only VMAT2 inhibitor that offers an effective starting dosage you can adjust based on response and tolerability1

EXPLORE DOSING

SEE 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 PROFILE

REFERENCES:

  1. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc.
  2. 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.
  3. 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.
  4. Data on file. Neurocrine Biosciences, Inc.
  5. 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.
  6. Lindenmayer J-P, Verghese C, Marder SR, et al. A long-term, open-label study of valbenazine for tardive dyskinesia. CNS Spectr. 2021;26(4):345-353.
  7. 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.
  8. Correll CU, Cutler AJ, Kane JM, McEvoy JP, Liang GS, O’Brien CF. Characterizing treatment effects of valbenazine for tardive dyskinesia: additional results from the KINECT 3 Study. J Clin Psychiatry. 2018;80(1):18m12278.
  9. 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. In press.
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Important Safety Information

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA, can increase the risk of depression and suicidal thoughts and

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.