Deutetrabenazine

(Austedo®)

Austedo®

Drug updated on 9/4/2024

Dosage FormExtended-release tablet (oral; 6mg, 12mg, 24mg); Tablet (oral; 6 mg, 9 mg, 12 mg)
Drug ClassVesicular monoamine transporter 2 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of adult patients with chorea associated with Huntington’s disease.
  • For the treatment of adult patients with tardive dyskinesia.

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Summary
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  • Austedo (deutetrabenazine) is indicated for the treatment of adult patients with chorea associated with Huntington's disease and for the treatment of adult patients with tardive dyskinesia.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Effectiveness of VMAT-2 inhibitors in psychosis: VMAT-2 inhibitors, including deutetrabenazine, were found to be more effective than placebo for achieving a 'slight improvement' in psychosis (RR = 1.77, 95% CI 1.03, 3.04), but not for 'moderate improvement' (RR 2.81, 95% CI 0.27, 29.17). The efficacy was comparable to active comparators for both 'slight improvement' (RR 1.05, 95% CI 0.6, 1.81) and 'moderate improvement' (RR 1.11, 95% CI 0.51, 2.42).
  • Deutetrabenazine and valbenazine in tardive dyskinesia: Deutetrabenazine (12 mg twice daily) demonstrated short-term efficacy in reducing tardive dyskinesia symptoms, similar to valbenazine, which showed a ≥50% reduction in Abnormal Involuntary Movement Scale score at 80 mg/day in both short-term and long-term studies. However, more long-term efficacy data for deutetrabenazine are needed.
  • General efficacy of new VMAT inhibitors: The strongest evidence for treating tardive dyskinesia comes from new VMAT inhibitors, including deutetrabenazine, though further long-term efficacy data are required.
  • There were no specific adverse effects or safety concerns detailed for VMAT-2 inhibitors, including deutetrabenazine, in the studies reviewed.
  • Both deutetrabenazine and valbenazine demonstrated tolerability in clinical trials; however, more long-term safety data are required for deutetrabenazine.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Austedo (deutetrabenazine) Prescribing Information.2023Teva Pharmaceuticals USA Inc., Parsippany, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines