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

Published online by Cambridge University Press:  15 June 2018

Karen E. Anderson ,
Mat D. Davis ,
Stewart A. Factor ,
Robert A. Hauser ,
L. Fredrik Jarskog ,
Joohi Jimenez-Shahed ,
Rajeev Kumar ,
Stanislaw Ochudlo ,
William G. Ondo  and
Hubert H. Fernandez
Karen E. Anderson
Affiliation:
Georgetown University, Washington, District of Columbia, USA
Mat D. Davis
Affiliation:
Teva Pharmaceutical Industries, Frazer, Pennsylvania, USA
Stewart A. Factor
Affiliation:
Emory University, Atlanta, Georgia, USA
Robert A. Hauser
Affiliation:
University of South Florida Parkinson’s Disease and Movement Disorders Center, Tampa, Florida, USA
L. Fredrik Jarskog
Affiliation:
University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
Joohi Jimenez-Shahed
Affiliation:
Baylor College of Medicine, Houston, Texas, USA
Rajeev Kumar
Affiliation:
Rocky Mountain Movement Disorders Center, Englewood, Colorado, USA
Stanislaw Ochudlo
Affiliation:
University Clinical Center of Silesian Medical University, Katowice, Poland
William G. Ondo
Affiliation:
Methodist Neurological Institute, Houston, Texas, USA
Hubert H. Fernandez
Affiliation:
Cleveland Clinic, Cleveland, Ohio, USA
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Abstract

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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-labelresults 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. Safetymeasures 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-termplacebo (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.

Presented at: The American Psychiatric Association 2017 Annual Meeting; May 20–24, 2017; San Diego, California, USA.

Funding Acknowledgements

This study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel.

Type
Abstracts
Information
CNS Spectrums , Volume 23 , Issue 1 , February 2018 , pp. 97
Copyright
© Cambridge University Press 2018