In the longest clinical trial to date for HD chorea (open-label extension, non-blinded)1,2

For a progressive condition, 3 years of continued chorea control1,3

ARC-HD Study: TMC Score Reduction Maintained Through 3 Years4

ARC-HD Study: Total Maximal Chorea (TMC) score from baseline to week 145, TMC reductions were seen in both Overnight Switch and Rollover cohorts at Week 8 and maintained through Week 145.

Patients in the ARC-HD study received the AUSTEDO BID formulation.1

FDA approved: Once-daily AUSTEDO XR formulation5

Sustained concentration over 24 hours4,5

  • Bioequivalence of once-daily AUSTEDO XR has been established in pharmacokinetic profile studies4†
  • Peak plasma concentrations (Cmax) of AUSTEDO® XR (deutetrabenazine) extended-release tablets are reached within approximately 3 hours5

Plasma Concentration at Steady State Over 24 Hours: AUSTEDO XR vs BID4‡

Bioequivalence Data: Plasma Concentration at Steady State Over 24 Hours in AUSTEDO XR vs BID, data support bioequivalence of XR and BID across the full dosing range of AUSTEDO.

Data support bioequivalence of XR and BID across the full dosing range of AUSTEDO.1,5

Based on active alpha and beta metabolites.4

*ARC-HD was divided into 2 study cohorts: patients who rolled over from the pivotal trial and patients who switched overnight from tetrabenazine.5

ARC-HD 3-year, open-label extension study design

ARC-HD was an open-label, single-arm, 2-cohort, 3-year extension study of the use of AUSTEDO in patients with HD chorea. The Rollover cohort had successfully completed FIRST-HD and underwent a 1-week washout prior to initiating 6 mg of AUSTEDO® (deutetrabenazine) tablets daily. The Switch cohort comprised patients with HD chorea who had been on a stable dose of tetrabenazine and were converted overnight to a dose of AUSTEDO predicted to provide comparable systemic exposure. A total of 119 patients with HD chorea were enrolled (Rollover cohort, n=82; Switch cohort, n=37). In both cohorts, dosage was titrated by 6 mg/day per week. Endpoints were changes in the UHDRS TMS and TMC scores from baseline to Week 8, as well as those from Week 8 to Week 145 (or end of treatment).1

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Watch: Dr. Fahd Amjad discuss long-term results through 3 years

HD, Huntington’s disease.

REFERENCES: 1. Frank S, Testa CM, Edmondson MC, et al. The safety of deutetrabenazine for chorea in Huntington Disease: an open-label extension study. CNS Drugs. 2022;36(11):1207-1216. doi:10.1007/s40263-022-00956-8 2. Jankovic J, Orman J. Tetrabenazine therapy of dystonia, chorea, tics, and other dyskinesias. Neurology. 1988;38:391-394. 3. Foroud T, Gray J, Ivashina J, Conneally PM. Differences in duration of Huntington’s disease based on age at onset. J Neurol Neurosurg Psychiatry. 1999;66(1):52-56. doi:10.1136/jnnp.66.1.52 4. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 5. AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc.