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Once-daily INGREZZA® (valbenazine) capsules

Efficacy in adults with tardive dyskinesia

At 6 weeks, patients experienced a ~30% reduction in tardive dyskinesia (TD)
severity with INGREZZA® (valbenazine) capsules 80 mg1-3,*

LS mean change from baseline in AIMS dyskinesia total score
through 6 weeks (ITT population)1-3

6-week primary endpoint graphLine graph showing the LS mean change from baseline in AIMS dyskinesia total score through 6 weeks for the ITT population. It shows that INGREZZA 80 mg significantly reduced AIMS scores compared to placebo at Week 6, with reductions in AIMS noted as early as Week 2. INGREZZA 40 mg also showed reductions in AIMS from baseline to Week 6.
6-week primary endpoint graphLine graph showing the LS mean change from baseline in AIMS dyskinesia total score through 6 weeks for the ITT population. It shows that INGREZZA 80 mg significantly reduced AIMS scores compared to placebo at Week 6, with reductions in AIMS noted as early as Week 2. INGREZZA 40 mg also showed reductions in AIMS from baseline to Week 6.
*

In a post hoc analysis of the primary efficacy endpoint of patients randomized to INGREZZA 80 mg at baseline through Week 6 (n=70).
†

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.
a

P≤0.001 dose that was statistically significantly different from placebo to control for multiple comparisons.
 

Mean baseline AIMS score (SD): placebo 9.9 (4.3), 40 mg 9.8 (4.1), 80 mg 10.4 (3.6).
 

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

STUDY DESIGN

INGREZZA 80 mg reduced uncontrolled movements
in 7 of 10 patients at 6 weeks1,3,‡

Percent of patients with specified magnitude of AIMS total score
improvement at the end of Week 61,3,‡

6-week responses graphBar graph showing the percent of patients with specified AIMS total score improvement at the end of Week 6. It shows that 71% of patients taking INGREZZA 80 mg experienced a 1-point or greater improvement in AIMS total score at Week 6. 57% of patients taking 40 mg experienced a 1-point or greater improvement in AIMS total score at Week 6.
6-week responses graphBar graph showing the percent of patients with specified AIMS total score improvement at the end of Week 6. It shows that 71% of patients taking INGREZZA 80 mg experienced a 1-point or greater improvement in AIMS total score at Week 6. 57% of patients taking 40 mg experienced a 1-point or greater improvement in AIMS total score at Week 6.
‡

Post hoc analysis included patients who had a baseline and a Week 6 AIMS total score. Reduction in uncontrolled movements as assessed by ≥1-point decrease in AIMS total score (n=70).

Mean baseline AIMS score (SD): placebo 9.9 (4.3), 40 mg 9.8 (4.1), 80 mg 10.4 (3.6).

AIMS, Abnormal Involuntary Movement Scale; SD, standard deviation.

STUDY DESIGN

Continued reductions in tardive dyskinesia (TD) severity
with once-daily dosing1,4

Extension study of INGREZZA 40 mg and INGREZZA 80 mg (ITT population)1,3,4

48-week endpoint graphLine graph showing the mean change from baseline in AIMS dyskinesia total score through 48 weeks. It shows that patients who remained on INGREZZA 40 mg and 80 mg through the end of the extended treatment period saw continued reductions in AIMS score. Patients in the initial placebo group who were re-randomized to INGREZZA 40 mg or INGREZZA 80 mg after week 6 also saw continued reduction in mean AIMS score through 48 weeks. In the 4-week post-treatment washout period, mean AIMS scores returned toward initial baseline scores for all INGREZZA groups.
48-week endpoint graphLine graph showing the mean change from baseline in AIMS dyskinesia total score through 48 weeks. It shows that patients who remained on INGREZZA 40 mg and 80 mg through the end of the extended treatment period saw continued reductions in AIMS score. Patients in the initial placebo group who were re-randomized to INGREZZA 40 mg or INGREZZA 80 mg after week 6 also saw continued reduction in mean AIMS score through 48 weeks. In the 4-week post-treatment washout period, mean AIMS scores returned toward initial baseline scores for all INGREZZA groups.
 

AIMS, Abnormal Involuntary Movement Scale; BL, baseline; DBPC, double-blind placebo-controlled; DFWO, drug-free washout; ITT, intent-to-treat.

STUDY DESIGN

~39% REDUCTION
IN TD SEVERITY WITH
INGREZZA 80 MG
AT 48 WEEKS1,4,§

§

In a post hoc analysis that included patients randomized to INGREZZA 80 mg at baseline and those who were re-randomized to INGREZZA 80 mg at Week 6 (n=65).

THE ONLY ONCE-DAILY
VMAT2 INHIBITOR

One-capsule, once-daily dosing with three effective dosing options sets INGREZZA apart from other VMAT2 inhibitors1

EXPLORE DOSING

SEE INGREZZA EFFICACY
FOR YOURSELF

Register for INGREZZA Insider to see real patient case reviews from the KINECT 3 and KINECT 4 clinical trials

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INGREZZA CLINICAL
SAFETY DATA

INGREZZA was studied across a broad range of TD patients

REVIEW SAFETY

See more results for INGREZZA

See why long-term treatment with INGREZZA 40 mg may be appropriate for some patients.a Review results of the KINECT 4 study—a phase 3, long-term, open-label study designed to be reflective of TD treatment in clinical practice.5

aRecommended dosage is 80 mg once daily, but patients may be maintained or
adjusted back to 40 mg based on individual treatment needs.

Watch expert perspective videos on INGREZZA

Featuring Amy LaCouture, RN, BSN, PMHNP-BC

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

Watch Why I Choose INGREZZA Video

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

Watch INGREZZA Case Study Video

These videos were sponsored and developed by Neurocrine Biosciences.
The speaker is a paid consultant of Neurocrine Biosciences.

REFERENCES: 1. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc. 2. 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. 3. Data on file. Neurocrine Biosciences, Inc. 4. 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. 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.

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

WARNINGS & PRECAUTIONS

Somnolence

INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.

QT Prolongation

INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Parkinsonism

INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.

ADVERSE REACTIONS

The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >Placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see INGREZZA full Prescribing Information

Indication and Important Safety Information

INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA.

+Expand-Collapse

Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

INDICATION & USAGE

INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

WARNINGS & PRECAUTIONS

Somnolence

INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.

QT Prolongation

INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Parkinsonism

INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.

ADVERSE REACTIONS

The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >Placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see INGREZZA full Prescribing Information

EXPAND FOR
GUIDELINES

INGREZZA is a recommended first-line TD treatment option.

See guidelines and recommendations
+

KINECT 3: INGREZZA pivotal study design1-4

Study overview

KINECT 3 study designpivotal study of INGREZZA (valbenazine) capsules in tardive dyskinesia
KINECT 3 study designpivotal study of INGREZZA (valbenazine) capsules in tardive dyskinesia9.99.710.4BLWeek 1DBPC PeriodDB Extension PeriodDFWO PeriodWeek 6Week 48Week 52Mean BLAIMS ScoresRE-RANDOMIZED INGREZZA 40 MGRE-RANDOMIZED INGREZZA 80 MGINGREZZA 40 MGINGREZZA 80 MGPLACEBO

Primary efficacy endpoint was mean change from baseline in AIMS dyskinesia total score at Week 6 for 80 mg compared to placebo1

KINECT 3 was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of INGREZZA 40 mg and 80 mg, administered once daily, compared to placebo.2,a

The study included 234 medically stable patients with a clinical diagnosis of schizophrenia, schizoaffective disorder, or mood disorder with moderate to severe DRBA-induced TD: 66% (150/227) of patients had a primary psychiatric diagnosis of schizophrenia or schizoaffective disorder; 34% (77/227) of patients had mood disorder.2,4,b

Extension study (6 to 52 weeks)

The INGREZZA extension study evaluated the safety and tolerability of INGREZZA 40 mg and 80 mg, administered once daily.4

The 6-week DBPC study period was followed by a double-blind INGREZZA extension period for 42 weeks (total treatment period 48 weeks). At the end of Week 6 (end of the DBPC treatment period), patients were re-consented to confirm their willingness to continue in the study. Patients initially randomized to placebo were re-randomized (1:1) to receive either 40 mg or 80 mg INGREZZA, and patients initially randomized to INGREZZA continued their current dose. Patients re-randomized to 80 mg started on 40 mg for 1 week. Patients then entered a 4-week posttreatment period with a final study visit at the end of Week 52.2-4

a

Patients randomized to 80 mg started on 40 mg for 1 week.
b

Safety population.
 

AIMS, Abnormal Involuntary Movement Scale; BL, baseline; DBPC, double-blind placebo-controlled; DFWO, drug-free washout.

Study endpoints

Primary endpoint

  • The primary efficacy endpoint was the mean change from baseline (CFB) at the end of Week 6 in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score for INGREZZA 80 mg compared to placebo1
  • The AIMS video recordings at baseline and throughout the study were reviewed at each study visit and scored by blinded, central AIMS video raters who scored the AIMS dyskinesia total score (sum of items 1–7 on AIMS) using a triple-blind consensus scoring process2

Secondary efficacy endpoint

  • The key secondary endpoint was the mean Clinical Global Impression of Change scale for Tardive Dyskinesia (CGI-TD) score compared to placebo2
    • CGI-TD is a clinician-rated scale used to assess the overall global improvement of TD on a 7-point scale (ranged 1 [very much improved] to 7 [very much worse])2

Statistical analysis

  • The primary efficacy analysis set was the intent-to-treat (ITT) analysis set, which included all patients in the safety analysis set who had a baseline (Day –1) AIMS dyskinesia total score value and at least one postbaseline AIMS dyskinesia total score value reported during the double-blind, placebo-controlled treatment period (ie, after randomization through Week 6 of the study)3
  • Patients who discontinued from the study prior to the scheduled Week 2 visit should have had AIMS data for the early termination (ET) visit, and were therefore expected to be included in this analysis set (the ET visit data in this case was treated as Week 2 data). The ITT analysis set was used for summaries and analyses of efficacy data3
  • In order to control the family-wise error rate for the AIMS and CGI-TD endpoints, as well as for the 2 INGREZZA treatment group comparisons to placebo, a fixed-sequence testing procedure was used2
  • The sequence of tests that were performed at Week 6 is summarized, in order, below. For each endpoint, a P value of ≤0.05 was required to continue the test sequence2,3:
    • AIMS dyskinesia total score mean CFB: INGREZZA 80 mg treatment group vs placebo treatment group
    • CGI-TD mean score: INGREZZA 80 mg treatment group vs placebo treatment group
    • AIMS dyskinesia total score mean CFB: INGREZZA 40 mg treatment group vs placebo treatment group
    • CGI-TD mean score: INGREZZA 40 mg treatment group vs placebo treatment group

Study population

  • Enrolled patients:
    • 234 medically stable males and females
    • Aged 18 to 85
    • Clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD (based on the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders [DSM–IV])
  • During the 6-week study period, 2 patients withdrew (1 patient in the placebo group and 1 patient in the INGREZZA 40 mg group), and 5 patients had no postbaseline safety data collected1,2
    • 66% (150/227) of patients had a primary psychiatric diagnosis of schizophrenia or schizoaffective disorder
    • 34% (77/227) of patients had mood disorder
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