Efficacy demonstrated for both
indications

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PIVOTAL TRIAL: AIM-TD

Significant and meaningful tardive dyskinesia (TD) symptom control at multiple doses with AUSTEDO (deutetrabenazine) tablets

AUSTEDO significantly reduced Abnormal Involuntary Movement Scale (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).1, 2

AIM-TD: Change in AIMS Total Score from Baseline to Week 12 (N=222)1, 2

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.
See AIM-td study design
RAPID RESPONSE:

Significant AIMS total score reduction was seen by Week 2 (exploratory analysis).1-3

OPEN-LABEL EXTENSION STUDY

AIMS score reduction observed throughout 145 weeks

Sustained results in an open-label extension study3,4

  • Reduction of the mean AIMS score was observed at Week 2 (1.7 ± 0.17)
  • Results were sustained throughout the long term with an AIMS reduction of 6.8 at Week 145
  • Adverse events over the long-term period were comparable to those in the pivotal trials

Mean Change in AIMS Score Over the Long-Term Period3

Mean change in AIMS score over the long-term period.
See Open-label study design

The mean total daily dose of AUSTEDO was 38.8 mg from the ARM-TD pivotal trial and 39.5 mg at Week 145 of the long-term period.3

  • After the pivotal trials, all patients completed a 1-week washout and then started on AUSTEDO at 12 mg/day, which was adjusted once per week in increments of 6 mg/day to identify a dose that adequately controlled dyskinesia and was tolerated by the patient4

The mean overall compliance rate was 90.2% for patients on a BID regimen of AUSTEDO at 2 years in the open-label extension study.3,4*

*Overall compliance based on pill counts.

RESPONDER ANALYSIS

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

AIM-TD: Response to Treatment Across Dosing Arms at Week 12 (N=222)1, 3

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.

PIVOTAL TRIAL: ARM-TD

Significant and meaningful control of TD symptoms at Week 12 (P=0.019) with AUSTEDO

Response-driven dosing with a mean dose of 38.3 mg/day at the end of the treatment period1,5

ARM-TD: Change in AIMS Total Score from Baseline to Week 12 (N=113)1, 5

ARM -TD: Change in AIMS total score from baseline to week 12 (N=113).
See Arm-td study design

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 therapy1,5
  • The maximum dose for patients taking a strong CYP2D6 inhibitor was 36 mg/day

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 group.5

STUDY-RESULTS

In the AIM-TD and ARM-TD pivotal trials1,3:

  • Control of TD symptoms was achieved while psychiatric scale scores, as measured by C-SSRS and HADS, generally remained stable
  • 4% of patients required dose reductions of AUSTEDO vs 2% of patients taking placebo

C-SSRS, Columbia-Suicide Severity Rating Scale; HADS, Hospital Anxiety and Depression Scale.

Learn more about why AUSTEDO may be right for the diverse treatment needs of your patients.
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References: 1. AUSTEDO® (deutetrabenazine) tablets 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. Published online June 28, 2017. doi: 10.1016/S2215-0366(17)30236-5 3. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 4. 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. 2019;90(12):1317–1323. doi:10.1136/jnnp-2018-319918 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. doi: 10.1212/WNL.0000000000003960