Clinical Data

3-year Study

In the longest TD clinical trial to date (open-label extension, non-blinded)^1-3

Rapid TD symptom control.* Sustained results across 3 years.^3-5

AIMS Score Reduction in the RIM-TD Study^1,3

Mean change in AIMS score over the long-term period. 6.6 point reduction vs baseline at Week 145 for patients with an average dose of ~39 mg/day.

Patients in the RIM-TD study received the AUSTEDO BID formulation.^3,6

Adverse events in this 3-year study were comparable to those in the 12-week pivotal trials.¹

3% of patients in the long-term study did not complete the study due to lack of efficacy.³

Mean dose at Week 145 was similar for younger and older patients (>39 mg/day).^7‡

The mean overall compliance rate was ~90% at 3 years^1§

Growing percentage of patients achieved ≥50% AIMS score improvement over time³

Download the reprint for more results from RIM-TD

FDA approved: Once-daily AUSTEDO XR formulation⁶

*Symptom control defined as change in AIMS total score observed as early as Week 2 in placebo-controlled studies.^4,5

^†Mean total dose.¹

^‡<55 years of age=younger; ≥55 years of age=older.⁷

^§Overall compliance based on pill counts.¹

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In a post hoc subgroup analysis of the longest TD clinical trial to date (open-label extension, non-blinded)^2,8

Sustained results across 3 years in patients with mood disorders^1,8

Mood Disorder Subgroup**: AIMS Score Reduction in the RIM-TD Study^1,8

AIMS score reduction in patients with mood disorders over the long term. 7.1-point reduction vs baseline.

Patients in the RIM-TD study received the AUSTEDO BID formulation.^3,6

**The mood disorder subgroup included patients with bipolar disorder and depression.⁸

^††Mean total dose.¹

Growing percentage of patients with mood disorders achieved ≥50% AIMS score improvement over time⁸

In a post hoc subgroup analysis of the longest TD clinical trial to date (open-label extension, non-blinded)^2,8

Sustained results across 3 years in patients with schizophrenia^1,8

Schizophrenia Subgroup^‡‡: AIMS Score Reduction in the RIM-TD Study^1,8

AIMS score reduction in patients with schizophrenia over the long term. 6.3-point reduction vs baseline.

Patients in the RIM-TD study received the AUSTEDO BID formulation.^3,6

^‡‡The schizophrenia subgroup included patients with schizophrenia and schizoaffective disorder.⁸

^§§Mean total dose.¹

Growing percentage of patients with schizophrenia achieved ≥50% AIMS score improvement over time⁸

RIM-TD study design

See Safety Profile

AIMS, Abnormal Involuntary Movement Scale; DRA, dopamine receptor antagonist; TD, tardive dyskinesia.

REFERENCES: 1. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 2. Marder SR, Singer C, Lindenmayer J-P, 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. 3. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13:773999. doi:10.3389/fneur.2022.773999 4. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. 5. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010. 6. AUSTEDO^® XR (deutetrabenazine) extended-release tablets and AUSTEDO^® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 7. Sajatovic M, Finkbeiner S, Wilhelm A, et al. Long-term safety and efficacy of deutetrabenazine in younger and older patients with tardive dyskinesia. Am J Geriatr Psychiatry. Published online August 15, 2021. doi:10.1016/j.jagp.2021.08.003 8. Hauser RA, Barkay H, Fernandez HH, et al. Effects of long-term deutetrabenazine treatment in patients with tardive dyskinesia and underlying psychiatric or mood disorders. Presented at: Psych Congress; October 29-November 1, 2021; San Antonio, TX. 9. Fernandez HH, Stamler D, Davis MD, et al. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. Published online July 10, 2019. doi:10.1136/jnnp-2018-319918 10. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13(suppl 1):773999. doi:10.3389/fneur.2022.773999

Important safety information

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO 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, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality 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. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.

Please see full Prescribing Information, including Boxed Warning.