Efficacy

INGREZZA reduced tardive dyskinesia (TD) severity at 6 weeks, with results you can start to see as early as 2 weeks1-3

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

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

b P<0.01 nominal P value when controlled for multiple comparisons.

*Exploratory analysis; P values provided for descriptive purposes:
(cP≤0.001, dP<0.05).

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

~30% reduction in TD severity at 6 weeks
with INGREZZA®
(valbenazine) capsules
80 mg1–3,e

e In a post hoc analysis of the primary efficacy endpoint of patients randomized to INGREZZA 80 mg at baseline through Week 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

~70% of patients on INGREZZA 80 mg saw reductions in their uncontrolled movements1,3,a

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

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.

aPost 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.

STUDY DESIGN

INGREZZA provided continued reduction of TD severity through 48 weeks1,4

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

      ~39% reduction in TD severity with
INGREZZA 80 mg at 48 weeks1,4,a

aIn 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.

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

STUDY DESIGN

INGREZZA clinical study design1-4

Primary efficacy endpoint for 80 mg (mean
change from baseline in AIMS dyskinesia total
score at Week 6)1

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

aPatients randomized to 80 mg started on 40 mg for 1 week.

bSafety population.

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

STUDY DESIGN

Watch expert perspective videos on INGREZZA

Featuring Amy LaCouture, RN, BSN, PMHNP-BC

Why I choose INGREZZA® (valbenazine) capsules
for adults with tardive dyskinesia (TD)

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

Watch more expert perspectives on THE INGREZZA YOUTUBE CHANNEL

REFERENCES: 1. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc; 2019. 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.