How AUSTEDO (deutetrabenazine) tablets was studied

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AUSTEDO was studied in a diverse TD patient population that reflects clinical practice

The clinical trials included a variety of tardive dyskinesia (TD) patients, from ages 18 to 81.1,2

Studied in patients with underlying psychiatric conditions, including:

  • Schizophrenia
  • Schizoaffective disorder
  • Bipolar disorder
  • Depression
OR
  • Gastrointestinal disorders

Studied in patients with comorbid conditions, including2:

  • Cardiovascular disorders
  • Lipid disorders
  • Metabolism/nutritional disorders, including diabetes

AUSTEDO was studied in patients taking a variety of concomitant medications. Patients’ regimens remained stable throughout the studies.1,2

56% of patients taking AUSTEDO were receiving antidepressants at baseline.2

64% of all patients were receiving atypical antipsychotics.1

12% of all patients were receiving typical or combination antipsychotics.1

24% of all patients were not receiving antipsychotics at baseline.1

AIM-TD pivotal clinical trial

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 Abnormal Involuntary Movement Scale (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 4 study arms were 9.5 (placebo), 9.6 (12 mg/day), 9.4 (24 mg/day), and 10.1 (36 mg/day).1,2

Open-label extension study

The open-label rollover study was a single-arm, long-term rollover 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 8.8.3

ARM-TD pivotal clinical trial

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, approximately 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.1,2,4

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.5

No one size fits all treatment of Austedo

Given the diverse TD patient population, there is no one-size-fits-all approach to tardive dyskinesia treatment.1,2

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. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 3. 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 4. 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 5. Abnormal Involuntary Movements Scale (AIMS) - overview. Center for Quality Assessment and Improvement in Mental Health website. Accessed April 16, 2020. http://www.cqaimh.org/pdf/tool_aims.pdf