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
Patients in the AIM-TD study received the AUSTEDO BID formulation.1
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
- In the pivotal studies, patients’ preexisting psychiatric stability was maintained through 12 weeks*
- See patient demographics from the studies
Rapid Response
Patients may see a response with AUSTEDO as early as 2 weeks (exploratory analysis)2
AIM-TD was a 12‑week, placebo‑controlled, fixed‑dose study of the use of AUSTEDO 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 4 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
Significant and meaningful control of TD symptoms at Week 12 with AUSTEDO1,5
Response-driven dosing with a mean dose of 38.3 mg/day at the end of the treatment period1
- AUSTEDO® (deutetrabenazine) tablets significantly reduced AIMS total score by 3.0 points (vs 1.6 in the placebo arm) at Week 12 (P=0.019)1,5
Change in AIMS Total Score From Baseline to Week 12 (N=113; P=0.019)3,5
~2x REDUCTION
in AIMS score with AUSTEDO vs placebo
Patients in the ARM-TD study received the AUSTEDO BID formulation.1
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.1,3,5
REFERENCES: 1. AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® 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. Anderson KE, Stamler D, Davis MD, et al. Supplementary appendix. Lancet Psychiatry. 2017;4(suppl 1):1-4. doi:10.1016/S2215-0366(17)30236-5 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.