Rapid and significant 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=0.001)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

AIMS, Abnormal Involuntary Movement Scale; LS, least squares.


71% of patients taking AUSTEDO 36 mg/day saw reductions in their uncontrolled movements3,4

Psychiatric scale scores generally remained stable2-4

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).1-3


*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

In the longest TD study to date (open-label extension, non-blinded)

Rapid TD symptom control as early as 2 weeks with sustained results observed through ~3 years3,5,6

AIMS Score Reduction in the RIM-TD Study3,6

Mean change in AIMS score over the long-term period. 6.6 point reduction vs baseline at Week 145 for patients taking 36 mg/day. Mean change in AIMS score over the long-term period. 6.6 point reduction vs baseline at Week 145 for patients taking 36 mg/day.

Symptom control defined as change in total AIMS score observed as early as Week 2 in placebo-controlled studies.3

Mean total daily dose.3

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

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

 

Over time, an increasing percentage of patients achieved AIMS score improvement6

  • 56% of patients achieved ≥50% reduction in total AIMS score at Week 80
  • 67% of patients achieved ≥50% reduction in total AIMS score at Week 145
AIMS Score Improvement Bar Chart. AIMS Score Improvement Bar Chart.

A majority of patients and physicians reported symptoms as “much improved” or “very much improved” at Week 145 (CGIC and PGIC)3

Adverse events were comparable to those in the pivotal trial. 3% of patients in the long-term study did not complete the study due to lack of efficacy.3,6

The mean overall compliance rate was ~90% at 3 years3||

||Overall compliance based on pill counts.3

RIM-TD long-term study design

The RIM-TD, long-term study was a single-arm, open-label extension study of patients from the 2 placebo-controlled trials, AIM-TD and ARM-TD. Patients who opted to roll over completed a 1-week washout and then started AUSTEDO at 12 mg/day, which was titrated by 6 mg/day weekly to identify a dose that adequately controlled TD and was tolerated by the patient.6,8

RIM-TD Study Design. RIM-TD Study Design. Table of baseline characteristics for the RIM-TD long-term study including patient demographics, comorbidities, and patient clinical characteristics. Table of baseline characteristics for the RIM-TD long-term study including patient demographics, comorbidities, and patient clinical characteristics.

Significant and meaningful control of TD symptoms at Week 12 with AUSTEDO1,9

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

  • AUSTEDO significantly reduced AIMS total score by 3.0 points (vs 1.6 in the placebo arm) at Week 12 (P=0.019)1,9

Change in AIMS Total Score From Baseline to Week 12 (N=113; P=0.019)9

 

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 placebo

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, 83% 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.1,3,9

CGIC, Clinical Global Impression of Change; DRA, dopamine receptor antagonist; PGIC, Patient Global Impression of Change.

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. Parsippany, NJ: 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://dx.doi.org/10.1016/S2215-0366(17)30236-5 5. 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. 6. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment is associated with continued improvement in tardive dyskinesia in the completed 3-year open-label extension study. Presented at: the 26th National Psychopharmacology Update Virtual Meeting; February 10-13, 2021. 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. Preprint posted online August 16, 2021. doi:10.1016/j.jagp.2021.08.003 8. 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. 9. 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.