Long-Term Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia: Results From an Open-Label, Long-Term Study

December 21, 2017
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This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Introduction: In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine showed clinically significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores at Week 12 compared with placebo, and was generally well tolerated.

Objective: To evaluate the long-term safety/tolerability and efficacy of deutetrabenazine in patients with TD. Week 54 open-label results are reported in this interim analysis.

Methods: Patients with TD who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12 mg/day, titrating up to a maximum total daily dose of 48 mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration period and a long-term maintenance phase. Safety measures included incidence of adverse events (AEs), serious AEs (SAEs), drug-related AEs, and AEs leading to withdrawal, dose reduction, or dose suspension. This analysis reports results up to Week 54.

Results: 304 patients enrolled in the extension study. There were 215 patient-years of exposure in this analysis, and exposure-adjusted incidence rates (EAIRs) of AEs (incidence/patient-years) were comparable to or lower than those observed with short-term deutetrabenazine treatment and placebo. The frequency of SAEs (EAIR 0.14) was similar to rates observed with short-term placebo (EAIR 0.33) and deutetrabenazine (EAIR range 0.06-0.33) treatment. AEs leading to study discontinuation (EAIR 0.08), dose reduction (EAIR 0.17), and dose suspension (EAIR 0.09) were uncommon.

Conclusions: Long-term treatment with deutetrabenazine was generally safe and well tolerated in patients with TD, and did not result in cumulative toxicity.

Authors: 
Karen Anderson, MD; Mat Davis, PhD; Stewart Factor, DO; Robert Hauser, MD, MBA; Lars Jarskog, MD; Joohi Jimenez-Shahed, MD; Rajeev Kumar, MD, FRCPC; Stanislaw Ochudlo, MD, PhD; William Ondo, MD; Hubert Fernandez, MD
Sponsoring Organization: 
Teva Pharmaceutical Industries
Year: 
2017
Tracks: 
Psychotic Disorders
Mood Disorders