Efficacy in adults with tardive dyskinesia

SELECT EFFICACY ENDPOINT:

6-week reduction 

6-week response

48-week reduction

Only INGREZZA offers tardive dyskinesia (TD) control made simple in just 6 weeks,
with results as early as 2 weeks1,2

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

LS mean change from BL in AIMS, graph
LS mean change from BL in AIMS, graph
*

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.

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.6

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

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,†

Percent magnitude of improvement from baseline for AIMS, chart
Percent magnitude of improvement from baseline for AIMS, chart

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.

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.6

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

Patients remaining on INGREZZA saw substantial reductions in TD severity1,4

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

Extension study of INGREZZA for TD, graph
Extension study of INGREZZA for TD, graph
 

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

Percent magnitude of improvement from baseline for AIMS, chart

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).

 

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

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.6

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

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

SIMPLE FROM
THE START

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

VIEW CASES

INGREZZA CLINICAL
SAFETY DATA

INGREZZA was studied across a broad range of TD patients

REVIEW SAFETY

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. 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.
  6. 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 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.

CONTRAINDICATIONS

INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in patients after taking the first or subsequent doses of INGREZZA. Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE.

Somnolence and Sedation

INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation. 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 or INGREZZA SPRINKLE.

QT Prolongation

INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA and INGREZZA SPRINKLE 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.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including INGREZZA. The management of NMS should include immediate discontinuation of INGREZZA or INGREZZA SPRINKLE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If treatment with INGREZZA or INGREZZA SPRINKLE is needed after recovery from NMS, patients should be monitored for signs of recurrence.

Parkinsonism

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

ADVERSE REACTIONS

The most common adverse reaction in patients with tardive dyskinesia (≥5% and twice the rate of placebo) is somnolence.

The most common adverse reactions in patients with chorea associated with Huntington’s disease (≥5% and twice the rate of placebo) are somnolence/lethargy/sedation, urticaria, rash, and insomnia.

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.

Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

Please see INGREZZA full Prescribing Information, including Boxed Warning.

+Expand-Collapse

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.

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.

CONTRAINDICATIONS

INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in patients after taking the first or subsequent doses of INGREZZA. Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE.

Somnolence and Sedation

INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation. 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 or INGREZZA SPRINKLE.

QT Prolongation

INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA and INGREZZA SPRINKLE 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.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including INGREZZA. The management of NMS should include immediate discontinuation of INGREZZA or INGREZZA SPRINKLE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If treatment with INGREZZA or INGREZZA SPRINKLE is needed after recovery from NMS, patients should be monitored for signs of recurrence.

Parkinsonism

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

ADVERSE REACTIONS

The most common adverse reaction in patients with tardive dyskinesia (≥5% and twice the rate of placebo) is somnolence.

The most common adverse reactions in patients with chorea associated with Huntington’s disease (≥5% and twice the rate of placebo) are somnolence/lethargy/sedation, urticaria, rash, and insomnia.

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.

Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

Please see INGREZZA full Prescribing Information, including Boxed Warning.