Rapid and meaningful tardive dyskinesia (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<0.05)1,2

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. 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.

>2x REDUCTION

in AIMS score with AUSTEDO
36 mg/day vs placebo

Most patients on 36 mg/day reported TD symptom control3,4

  • 72% of patients taking AUSTEDO 36 mg/day saw reductions in their uncontrolled movements

Psychiatric scale scores generally remained stable3,4

Rapid Response

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

AIM-TD study design

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

*Two-week exploratory analysis.

Symptom control in the longest TD study to date (145 weeks)3,5,6

Sustained results observed in the open-label extension (OLE), non-blinded, all-AUSTEDO study (N=343)3,5

  • Reduction of the mean AIMS score was observed starting at Week 25
  • Through to Week 145: adverse events were comparable to those in the pivotal trial5

AIMS Score Reduction in an Open-Labellabel Extension3

Mean change in AIMS score over the long-term period. Mean change in AIMS score over the long-term period.

6.8 POINT

reducion vs baseline

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 patient.5

2% of patients in the open-label extension did not complete the study due to lack of efficacy.5

The mean overall compliance rate was 90.2% at 2 years3‡

At Week 80:

  • ~60% of patients saw 50% or more improvement in total AIMS score (n=66)3,5
  • The majority of patients were taking 42 mg to 48 mg of AUSTEDO5

Psychiatric stability was sustained in the long term5

  • In an open-label extension study, patients’ preexisting psychiatric scale scores generally remained stable
Open-label extension study design

The open-label extension study was a single-arm, long-term extension study of patients from 2 placebo-controlled trials, AIM-TD and ARM-TD. All patients were treated with AUSTEDO in this study. Patients were 56% female and 44% male. Average age was 56 years. Mean baseline total motor AIMS score was 8.8.5

Overall compliance based on pill counts.

Significant and meaningful control of TD symptoms at Week 12 with AUSTEDO7

Response-driven dosing with a mean dose of 38.3 mg/day at the end of the treatment period1,7

  • AUSTEDO significantly reduced AIMS total score by 3.0 points (vs 1.6 in the placebo arm) at Week 12 (P=0.019)1,7

Change in AIMS Total Score from Baseline to Week 12 (N=113)7

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

~2x REDUCTION

in AIMS score with AUSTEDO vs placebo7

ARM-TD study design

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 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 antipsychotic drug 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.1,7

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 and at Week 106 in the OLE of AUSTEDO; 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 106-week OLE (AIM-TD and ARM-TD).2,5

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Watch Dr. Rajeev Kumar talk about AUSTEDO for the treatment of TD

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. 3. Data on file. North Wales, PA: Teva Neuroscience, Inc. 4. Appendix to: 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 [Epub 28 Jun 2017]. Lancet Psychiatry. https://doi.org/10.1016/S2215-0366(17)30236-5 Accessed June 18, 2020. 5. 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 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. 7. 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.