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

Background: In the 12-week ARM-TD and AIM-TD studies, DTB showed clinically significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores at Week 12 compared with placebo (PBO), and was generally well tolerated. There is a significant unmet need for a TD treatment that is well tolerated over an extended period while allowing the maintenance of concomitant treatment for underlying psychiatric comorbidities.

Methods: Patients who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started DTB 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 of up to 104 weeks. Safety measures included incidence of adverse events (AEs), serious AEs (SAEs), drug-related AEs, and AEs leading to withdrawal, dose reduction, or dose suspension.

Results: Of 304 patients enrolled, 202 had previously received DTB and 102 received PBO. As of the cutoff date, 6/30/2016, patients had clinically significant improvements in AIMS scores (–5.1 points) and Clinical Global Impression of Change (72% “much improved” or “very much improved”). Exposure-adjusted incidence rates (EAIRs) of AEs (incidence/patient-years) were similar between patients previously treated with DTB (2.04) or PBO (1.74). The most common AEs (by EAIR) were similar between DTB and PBO: anxiety (0.12), somnolence (0.11), depression (0.11), headache (0.10), diarrhea (0.08), and nasopharyngitis (0.08). Neuropsychiatric AE rates were low and similar between prior treatment groups, and >90% were mild to moderate in severity. SAEs were experienced by 29 patients (EAIR: 0.14); three SAEs were considered possibly related to DTB (stress urinary incontinence, intentional overdose, suicide attempt). Discontinuations (EAIR: 0.08 [18/212.4]), dose reductions (EAIR: 0.17 [33/194.3]), and dose suspensions (EAIR: 0.09 [19/204.7]) due to AEs were uncommon.

Conclusions: DTB was generally safe and well tolerated for up to 54 weeks in patients with TD, with low rates of neuropsychiatric AEs.

Presented at: APA annual meeting; May 20–24, 2017; San Diego, CA, USA

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MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-safety-of-deutetrabenazine-for-the-treatment-of-tardive-dyskinesia-results-from-an-open-label-long-term-study/