Evaluation of the long-term safety and efficacy of deutetrabenazine for tardive dyskinesia

Background Deutetrabenazine is a vesicular monoamine transporter 2 inhibitor with established short-term efficacy and safety for the treatment of tardive dyskinesia. Tardive dyskinesia is a chronic condition that requires treatment beyond the 12 weeks during which deutetrabenazine was originally studied. Objective This article reviews the long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. Methods A systematic literature search using OVID Medline identified studies examining the long-term safety and efficacy of deutetrabenazine in adult patients with TD. Studies included adults aged 18 years or older with TD who received deutetrabenazine for more than 12 weeks. The primary and sole data source was a 3-year open-label extension study. Additional content was drawn from associated post-hoc analyses and conference presentations by Teva Neurosciences, Inc., featuring original data. Results In the 3-year, open-label extension study (n=343), deutetrabenazine was associated with clinically meaningful and sustained improvements in abnormal movements associated with TD, as assessed using the Abnormal Involuntary Movement Scale, the gold standard for evaluating TD. The majority of patients achieved treatment success (i.e., global improvement of TD severity) as defined by the Clinical Global Impression of Change and the Patient Global Impression of Change scales. It was also associated with low rates of adverse events and serious adverse events, with most adverse events rated as mild-to moderate, resulting in overall good tolerability. Post hoc analyses of the open-label extension study provided further evidence of its long-term safety and efficacy regardless of patient characteristics, including age, sex, race, baseline dopamine receptor antagonist use, or psychiatric diagnoses. Conclusion Overall, deutetrabenazine is a safe, tolerable, and effective long-term treatment for patients with tardive dyskinesia.