Long-term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia (2003)

Objective: To assess the long-term safety and efficacy of deutetrabenazine in younger ( Background: TD is an involuntary movement disorder that is more prevalent in older patients. Deutetrabenazine is FDA approved for treatment of TD in adults based on 2 pivotal phase 3 studies in patients with baseline Abnormal Involuntary Movement Scale (AIMS) score ≥6 (ARM-TD and AIM-TD), which demonstrated significant improvements in AIMS score versus placebo over 12 weeks. Design/Methods: Patients who completed ARM-TD or AIM-TD were enrolled in a single-arm, open-label extension (OLE) study. This post hoc analysis assessed change and percent change from baseline in AIMS score, response rates for ≥50% AIMS improvement, Patient Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC), and safety in younger ( Results: 343 participants enrolled in the OLE, including 124 younger patients and 219 older patients. At Week 145, mean±SE total deutetrabenazine dose was 39.3±1.37 mg/day and 39.3±1.05 mg/day in younger and older patients, respectively. At Week 145, mean±SE changes from baseline in AIMS score were −6.7±0.61 and −6.4±0.47 in younger and older patients, respectively (percent changes of −60.9%±4.06% and −53.8%±3.06%, respectively); the majority of younger and older patients achieved treatment success per CGIC (66% and 76%) and PGIC (both 63%), and 75% of younger and 61% of older patients achieved ≥50% AIMS response. Deutetrabenazine was generally well tolerated in both groups. Exposure-adjusted incidence rates (incidence/patient-years) were Conclusions: Deutetrabenazine treatment was associated with sustained improvements in AIMS score and was well tolerated in both younger and older TD patients. Disclosure: Dr. Sajatovic has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bracket, Otsuka, Sunovion, Neurocrine, Supernus, Health Analytics. Dr. Sajatovic has received royalty, license fees, or contractual rights payments from Springer Press, Johns Hopkins University Press, Oxford Press, UpToDate. Dr. Sajatovic has received research support from Otsuka, Merck, Alkermes, Janssen,. Dr. Wilhelm has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Teva Pharmaceuticals, USA.. Dr. Finkbeiner has nothing to disclose. Dr. Barkay has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Teva Pharmaceuticals, Israel. Dr. Chaijale has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Teva Pharmaceuticals. Dr. Gross has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals, USA. Dr. Gordon has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals.