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Psych Congress  

Long-term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia

Authors  

Martha Sajatovic, MD-University Hospitals Cleveland Medical Center Case Western Reserve University School of Medicine; Amanda Wilhelm, PhD-Teva Pharmaceuticals; Stacy Finkbeiner, PhD-Teva Pharmaceuticals; Hadas Barkay, PhD-Teva Pharmaceuticals; Nayla Chaijale, PhD-Teva Pharmaceuticals; Nicholas Gross, MS-Teva Pharmaceuticals; Mark Forrest Gordon, MD-Teva Pharmaceuticals

Sponsor  
Teva Pharmaceutical Industries Ltd.

Background: Tardive dyskinesia (TD) is an involuntary movement disorder that is more prevalent in older patients. However, there is limited information on TD treatment for this population. In two 12-week pivotal trials (ARM-TD and AIM-TD), TD patients demonstrated significant improvements in Abnormal Involuntary Movement Scale (AIMS) score with deutetrabenazine versus placebo.

Methods: Patients who completed ARM-TD or AIM-TD enrolled in an open-label extension (OLE) study. This post hoc analysis assessed change and percent change from baseline in AIMS score, response rates for ‚â•50% AIMS improvement, Patient Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC), and safety in younger (< 55 years) and older (≥55 years) patients.

Results: This analysis included 119 younger and 218 older patients enrolled in the OLE. Data presented at Week 145 (mean[SE]): total deutetrabenazine dose was 39.4(1.39)mg/day and 39.5(1.04)mg/day in younger and older patients, respectively. Changes from baseline in AIMS score were ‚-6.7(0.62) and -6.5(0.47), respectively (percent changes of –61.4%±4.10% and –54.6%±3.01%). The majority of younger and older patients achieved treatment success per CGIC (67% and 76%) and PGIC (64% and 63%) and achieved ≥50% AIMS response (76% and 62%). Deutetrabenazine was generally well tolerated in both groups. Exposure-adjusted incidence rates (incidence/patient-years) were < 0.01 and 0.02 for akathisia, 0.07 (both) for somnolence and sedation, 0.04 and 0.11 for parkinson-like events, and 0.06 and 0.09 for depression in younger and older patients, respectively.

Conclusions: Deutetrabenazine treatment was associated with sustained improvements in AIMS score and was well tolerated in both younger and older TD patients.

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