In the longest TD clinical trial to date (open-label extension, non-blinded)1-3
Rapid TD symptom control.* Sustained results across 3 years.3-5
AIMS Score Reduction in the RIM-TD Study1,3

Patients in the RIM-TD study received the AUSTEDO BID formulation.3,6
Adverse events in this 3-year study were comparable to those in the 12-week pivotal trials.1
3% of patients in the long-term study did not complete the study due to lack of efficacy.3
Mean dose at Week 145 was similar for younger and older patients (>39 mg/day).7‡
The mean overall compliance rate was ~90% at 3 years1§
Growing percentage of patients achieved ≥50% AIMS score improvement over time3
Patients With ≥50% Reduction in AIMS Total Score3

Stable dosing following titration: average dose was ~39 mg/day from Week 15 through Week 145.
Sustained concentration over 24 hours1,6
- Bioequivalence of once-daily AUSTEDO XR has been established in pharmacokinetic profile studies1||
- Peak plasma concentrations (Cmax) of AUSTEDO® XR (deutetrabenazine) extended-release tablets are reached within approximately 3 hours6
Plasma Concentration at Steady State Over 24 Hours: AUSTEDO XR vs BID1¶

||Data support bioequivalence of XR and BID across the full dosing range of AUSTEDO.6
¶Based on active alpha and beta metabolites.1
*Symptom control defined as change in AIMS total score observed as early as Week 2 in placebo-controlled studies.4,5
†Mean total dose.1
‡<55 years of age=younger; ≥55 years of age=older.7
§Overall compliance based on pill counts.1
In a post hoc subgroup analysis of the longest TD clinical trial to date (open-label extension, non-blinded)2,8
Sustained results across 3 years in patients with mood disorders1,8
Mood Disorder Subgroup**: AIMS Score Reduction in the RIM-TD Study1,8

Patients in the RIM-TD study received the AUSTEDO BID formulation.3,6
**The mood disorder subgroup included patients with bipolar disorder and depression.8
††Mean total dose.1
Growing percentage of patients with mood disorders achieved ≥50% AIMS score improvement over time8
Patients With ≥50% Reduction in AIMS Total Score8

In a post hoc subgroup analysis of the longest TD clinical trial to date (open-label extension, non-blinded)2,8
Sustained results across 3 years in patients with schizophrenia1,8
Schizophrenia Subgroup‡‡: AIMS Score Reduction in the RIM-TD Study1,8

Patients in the RIM-TD study received the AUSTEDO BID formulation.3,6
‡‡The schizophrenia subgroup included patients with schizophrenia and schizoaffective disorder.8
§§Mean total dose.1
Growing percentage of patients with schizophrenia achieved ≥50% AIMS score improvement over time8
Patients With ≥50% Reduction in AIMS Total Score

RIM-TD was a single-arm, open-label extension study of the use of AUSTEDO in 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.9


AIMS, Abnormal Involuntary Movement Scale; DRA, dopamine receptor antagonist; TD, tardive dyskinesia.
REFERENCES: 1. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 2. 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. 3. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13:773999. doi:10.3389/fneur.2022.773999 4. 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. 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. 6. AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 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. Published online August 15, 2021. doi:10.1016/j.jagp.2021.08.003 8. Hauser RA, Barkay H, Fernandez HH, et al. Effects of long-term deutetrabenazine treatment in patients with tardive dyskinesia and underlying psychiatric or mood disorders. Presented at: Psych Congress; October 29-November 1, 2021; San Antonio, TX. 9. 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. Published online July 10, 2019. doi:10.1136/jnnp-2018-319918 10. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13(suppl 1):773999. doi:10.3389/fneur.2022.773999