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46 Confirmed Safety of Deutetrabenazine for Tardive Dyskinesia in a 2-Year Open-label Extension Study

Published online by Cambridge University Press:  12 March 2019

Hubert H. Fernandez
Affiliation:
Cleveland Clinic, Center for Neurological Restoration, Cleveland, Ohio, USA
David Stamler
Affiliation:
Teva Pharmaceuticals, La Jolla, California, USA
Mat D. Davis
Affiliation:
Teva Pharmaceuticals, 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
Joohi Jimenez-Shahed
Affiliation:
Baylor College of Medicine, Houston, Texas, USA
William G. Ondo
Affiliation:
Methodist Neurological Institute, Houston, Texas, USA; Weill Cornell Medical College, New York, New York, USA
L. Fredrik Jarskog
Affiliation:
University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
Scott W. Woods
Affiliation:
Yale School of Medicine, New Haven, Connecticut, USA
Mark S. LeDoux
Affiliation:
University of Tennessee Health Science Center, Memphis, Tennessee, USA
David R. Shprecher
Affiliation:
University of Utah, Salt Lake City, Utah, USA; Banner Sun Health Research Institute, Sun City, Arizona, USA
Karen E. Anderson
Affiliation:
Georgetown University, Washington, District of Columbia, USA
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Abstract

Study Objective

To evaluate the long-term safety and tolerability of deutetrabenazine in patients with tardive dyskinesia (TD) at 2years.

Background

In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine showed clinically significant improvements in Abnormal Involuntary Movement Scale scores compared with placebo, and there were low rates of overall adverse events (AEs) and discontinuations associated with deutetrabenazine.

Method

Patients who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12mg/day, titrating up to a maximum total daily dose of 48mg/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 AEs, serious AEs (SAEs), and AEs leading to withdrawal, dose reduction, or dose suspension. Exposure-adjusted incidence rates (EAIRs; incidence/patient-years) were used to compare AE frequencies for long-term treatment with those for short-term treatment (ARM-TD and AIM-TD). This analysis reports results up to 2 years (Week106).

Results

343 patients were enrolled (111 patients received placebo in the parent study and 232 received deutetrabenazine). There were 331.4 patient-years of exposure in this analysis. Through Week 106, EAIRs of AEs were comparable to or lower than those observed with short-term deutetrabenazine and placebo, including AEs of interest (akathisia/restlessness [long-term EAIR: 0.02; short-term EAIR range: 0–0.25], anxiety [0.09; 0.13–0.21], depression [0.09; 0.04–0.13], diarrhea [0.06; 0.06–0.34], parkinsonism [0.01; 0–0.08], somnolence/sedation [0.09; 0.06–0.81], and suicidality [0.02; 0–0.13]). The frequency of SAEs (EAIR 0.15) was similar to those observed with short-term placebo (0.33) and deutetrabenazine (range 0.06–0.33) treatment. AEs leading to withdrawal (0.08), dose reduction (0.17), and dose suspension (0.06) were uncommon.

Conclusions

These results confirm the safety outcomes seen in the ARM-TD and AIM-TD parent studies, demonstrating that deutetrabenazine is well tolerated for long-term use in TD patients.

Presented at: American Academy of Neurology Annual Meeting; April 21–27, 2018, Los Angeles, California,USA

Funding Acknowledgements: Funding: This study was supported by Teva Pharmaceuticals, Petach Tikva, Israel

Type
Abstracts
Copyright
© Cambridge University Press 2019 

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46 Confirmed Safety of Deutetrabenazine for Tardive Dyskinesia in a 2-Year Open-label Extension Study
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