What is the role of deutetrabenazine (Austedo) as a treatment for tardive dyskinesia (TD)?

Updated: Oct 17, 2018
  • Author: James Robert Brasic, MD, MPH; Chief Editor: Selim R Benbadis, MD  more...
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Answer

Answer

Deutetrabenazine (Austedo) is a novel, highly selective vesicular monoamine transporter type 2 (VMAT2) inhibitor. FDA has approved deutetrabenazine tablets for the treatment of adults with tardive dyskinesia (TD). The approval was based in part on the results of two 12-week, randomized, double-blind, placebo-controlled, multicenter trials, which compared changes in involuntary movements in 335 patients with TD who took deutetrabenazine or placebo. 

For the first trial, 222 patients were randomly assigned to deutetrabenazine (12 mg/day, 24 mg/day, 36 mg/day) or placebo. Two dosage levels—24 mg/day and 36 mg/day—were associated with statistically significant improvement in patients’ Abnormal Involuntary Movement Scale (AIMS) score, from baseline to week 12, compared with placebo. [60]

For the second trial, 113 patients received daily doses of placebo or deutetrabenazine, starting at 12 mg/day, with titration up to 48 mg/day over a six-week period. This was followed by a six-week maintenance period at an average dose of 38.3 mg/day. From baseline to week 12, the AIMS total score decreased significantly in patients receiving deutetrabenazine compared with those receiving placebo. [61]


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