Rapid response. Significant TD symptom control^1,2

AUSTEDO significantly reduced AIMS total score by 3.3 points from baseline in the 36 mg/day arm (vs 1.4 with placebo) at Week 12 (P=0.001)

Change in AIMS Total Score From Baseline to Week 12 (N=222)

AIM-TD: >2x reduction in AIMS score with AUSTEDO® (deutetrabenazine) tablets vs placebo from Baseline to Week 12 (N=222). 1.4 point reduction vs baseline, -1.9 point treatment effect vs placebo, 3.3 point reduction vs baseline.

Patients in the AIM-TD study received the AUSTEDO BID formulation.¹

AIMS, Abnormal Involuntary Movement Scale; LS, least squares; TD, tardive dyskinesia.

71% of patients taking AUSTEDO 36 mg/day saw reductions in their uncontrolled movements^3,4

Psychiatric scale scores generally remained stable^2-4

In the pivotal studies, patients’ preexisting psychiatric stability was maintained through 12 weeks*
See patient demographics from the studies

Patients may see a response with AUSTEDO as early as 2 weeks (exploratory analysis)²

AIM-TD study design

*Evaluations performed using: 1. The Hospital Anxiety and Depression Scale (HADS), a self-report questionnaire that offers an efficient way to screen patients for psychological comorbidities, showed no worsening at Week 12 in AIM-TD and ARM-TD; 2. The Columbia-Suicide Severity Rating Scale (C-SSRS), a measure used to identify and assess individuals at risk for suicide, was assessed at any visit during the 12-week randomized trials (AIM-TD and ARM-TD).^2-4

Significant and meaningful control of TD symptoms at Week 12 with AUSTEDO^1,5

Response-driven dosing with a mean dose of 38.3 mg/day at the end of the treatment period¹

AUSTEDO^® (deutetrabenazine) tablets significantly reduced AIMS total score by 3.0 points (vs 1.6 in the placebo arm) at Week 12 (P=0.019)^1,5

Change in AIMS Total Score From Baseline to Week 12 (N=113; P=0.019)⁵

~2x REDUCTION

in AIMS score with AUSTEDO vs placebo^3,5

Patients in the ARM-TD study received the AUSTEDO BID formulation.¹

ARM-TD study design

SEE 3-YEAR STUDY VIEW SAFETY & TOLERABILITY PROFILE

REFERENCES: 1. AUSTEDO^® XR (deutetrabenazine) extended-release tablets and AUSTEDO^® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. 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. 3. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 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. Supplementary appendix. Lancet Psychiatry. 2017;4(suppl 1):1-4. 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.

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.

Rapid response. Significant TD symptom control1,2

AUSTEDO significantly reduced AIMS total score by 3.3 points from baseline in the 36 mg/day arm (vs 1.4 with placebo) at Week 12 (P=0.001)

~2x REDUCTION

Rapid response. Significant TD symptom control^1,2