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ARM-TD

ARM-TD: Significant and meaningful control of TD symptoms with a proven safety and tolerability profile

AUSTEDO® tablets significantly reduced Abnormal Involuntary Movement Scale (AIMS) total score by 3.0 points (vs 1.6 in the placebo arm) at Week 12 (P=0.019, treatment effect of -1.4 points)1,2

Response-driven dosing with a mean dose of 38.3 mg/day at the end of the treatment period1,2

ARM-TD: Change in AIMS Total Score from Baseline to Week 12 (N=113; P=0.019)1,2

ARM -TD: Change in AIMS Total Score from Baseline to Week 12 (N=113; P=0.019). Placebo vs AUSTEDO® (deutetrabenazine) tablets. 1.6 Point reduction vs baseline, -1.4 Point treatment effect vs placebo, 3.0 Point reduction vs baseline.

ARM-TD was a randomized, double-blind, placebo-controlled, phase 2/3 trial to evaluate the efficacy, safety, and tolerability of AUSTEDO® in patients with tardive dyskinesia (TD). The primary efficacy endpoint was change in the AIMS total score from baseline to Week 12. Among the total population, 80% of patients were taking an APD at baseline. Patients were evenly distributed in terms of gender and the average age was 55 years. The mean AIMS total score at baseline was 9.7 in the AUSTEDO® group and 9.6 in the placebo group.1,2

In ARM-TD

  • A 6-week titration dosing strategy was utilized (initial dose of 12 mg/day, divided into 2 daily doses taken with food, titrated weekly by 6 mg/day for a max dose of 48 mg/day), followed by 6 weeks of maintenance therapy1,2
    • The maximum dose for patients taking a strong CYP2D6 inhibitor was 36 mg/day

The AIMS total score (sum of items 1-7) measures severity of TD across 7 body areas, covering potential TD manifestations for a comprehensive evaluation of TD severity. Four areas are related to orofacial movements and 3 cover truncal and extremity movements.1,3

In this study, discontinuation due to adverse events occurred in 1 patient (1.7%) in the AUSTEDO® group and 2 patients (3.4%) in the placebo group2

AIM-TD

AIM-TD: Significant and meaningful control of TD symptoms with a proven safety and tolerability profile

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 <0.05, treatment effect of -1.9 points)1,4

AIM-TD: Change in AIMS Total Score from Baseline to Week 12 (N=222)1,4

AIM -TD: Change in AIMS Total Score from Baseline to Week 12 (N=222). Placebo vs AUSTEDO® (deutetrabenazine) tablets. 1.4 Point reduction vs baseline, -1.9 Point treatment effect vs placebo, 3.3 Point reduction vs baseline.

AIM-TD was a 12-week, placebo-controlled, fixed-dose trial in adults with TD. Patients were randomized 1:1:1:1 to 12 mg/day AUSTEDO®, 24 mg/day AUSTEDO®, 36 mg/day AUSTEDO®, or placebo. Treatment duration included a 4-week dose escalation period and an 8-week maintenance period. The primary efficacy endpoint was change in the AIMS total score from baseline to Week 12 in the 36 mg/day arm vs placebo. Patients were 52% female and 48% male. Average age was 57 years. Mean baseline AIMS total scores in the four study arms were 9.5 (placebo), 9.6 (12 mg/day), 9.4 (24 mg/day), and 10.1 (36 mg/day).1,3

  • Significant AIMS total score reduction was seen at 2 weeks (exploratory analysis)4

Overall, in AIM-TD and ARM-TD1,3

  • 64% of patients were receiving atypical antipsychotics at baseline
  • 12% of patients were receiving typical or combination antipsychotics at baseline
  • 24% of patients were not receiving antipsychotics at baseline
  • 56% of patients treated with AUSTEDO® were concomitantly taking antidepressant therapy at baseline

All medications were required to remain stable throughout the trials.1,3

In AIM-TD and ARM-TD, psychiatric scale scores, as measured by Columbia-Suicide Severity Rating Scale (C-SSRS) and Hospital Anxiety and Depression Scale (HADS), remained similar across groups2,3

AIM-TD: 41% of patients in the 36 mg/day arm had a ≥4-point improvement in AIMS total score vs 25% in the placebo arm1

Among patients in the AUSTEDO® 36 mg/day arm, 76% showed a treatment response ≥1 point vs 54% in the placebo arm at Week 121

AIM-TD: Response to Treatment Across Dosing Arms at Week 12 (N=222)1

AIM -TD: Response in Treatment Across Dosing Arms at Week 12 (N=222) AUSTEDO® (deutetrabenazine) tablets at 12 mg, 24 mg, and 36 mg vs Placebo.

AIM-TD was a 12-week, placebo-controlled, fixed-dose trial in adults with TD. Patients were randomized 1:1:1:1 to 12 mg/day AUSTEDO®, 24 mg/day AUSTEDO®, 36 mg/day AUSTEDO®, or placebo. Treatment duration included a 4-week dose escalation period and an 8-week maintenance period. The primary efficacy endpoint was change in the AIMS total score from baseline to Week 12 in the 36 mg/day arm vs placebo. Patients were 52% female and 48% male. Average age was 57 years. Mean baseline AIMS total scores in the four study arms were 9.5 (placebo), 9.6 (12 mg/day), 9.4 (24 mg/day), and 10.1 (36 mg/day).1,3

In AIM-TD and ARM-TD, 4% of patients required dose reductions of AUSTEDO® vs 2% of patients taking placebo1

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Indications and Usage

AUSTEDO® is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.

Important Safety Information

Depression and Suicidality in Patients with Huntington’s Disease: 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® is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO® is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO® is 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 (Xenazine®) or valbenazine (Ingrezza®).

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

QTc Prolongation: Tetrabenazine, a closely related VMAT2 inhibitor, causes an increase in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO® who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor. Dose reduction may be necessary. The use of AUSTEDO® in combination with other drugs known to prolong QTc may result in clinically significant QT prolongations. For patients requiring AUSTEDO® doses greater than 24 mg per day who are using AUSTEDO® with other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of AUSTEDO® or the other drugs. 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®; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: 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® dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism in Patients with Huntington’s Disease: AUSTEDO® may cause parkinsonism in patients with Huntington’s disease. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the 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®. 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® 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®.

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.

CYP2D6 Metabolism: In patients who are poor CYP2D6 metabolizers or are taking strong CYP2D6 inhibitors, the total daily dosage of AUSTEDO® should not exceed 36 mg (maximum single dose of 18 mg).

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.

Please see accompanying full Prescribing Information, including Boxed Warning.

References: 1. AUSTEDO® (deutetrabenazine) tablets Prescribing Information. Teva Pharmaceuticals USA, Inc. August 2017. 2. 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. 3. Data on file. 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. Lancet Psychiatry. 2017;4(8):595-604.