Long-Term Efficacy and Safety of Deutetrabenazine in Postmenopausal Women With Tardive Dyskinesia

Abstract: Introduction: Advanced age and female sex are risk factors for tardive dyskinesia (TD). This post hoc analysis assessed the long-term efficacy and safety of deutetrabenazine, an FDA-approved treatment for TD in adults, in women who were postmenopausal. Methods: This post hoc analysis of a 3-year open-label extension study of deutetrabenazine (≤48 mg/day, individually titrated for dyskinesia control and tolerability) included women with TD who were postmenopausal (amenorrheic ≥1 year with serum follicle-stimulating hormone level consistent with postmenopausal status). Change from baseline in Abnormal Involuntary Movement Scale (AIMS) and proportion of patients with treatment success (“much improved”/”very much improved” on Patient/Clinical Global Impression of Change scales [PGIC/CGIC]) were assessed. Adverse event rates were calculated as exposure-adjusted incidence rates (EAIRs; incidence/patient-year). Results: Among 137 women who were postmenopausal at baseline (mean age, 62.7 years; 85% White; mean time since TD diagnosis, 5.5 years), 52% had schizophrenia/schizoaffective disorder and 48% had mood disorders (bipolar/depression/other). Mean (SE) deutetrabenazine dose was 38.6 (0.84) mg/day at week 15 and 39.3 (1.16) mg/day at week 145. At week 15 (n=123) and week 145 (n=77), mean (SE) changes from baseline AIMS score were –4.5 (0.42) and –7.2 (0.52); 61% and 68% achieved PGIC treatment success, and 63% and 82% achieved CGIC treatment success. EAIRs were low (any, 1.69; serious, 0.10; treatment-related, 0.41; leading to discontinuation, 0.05) and consistent with the overall study population. Conclusions: In women who were postmenopausal, long-term deutetrabenazine treatment provided clinically meaningful improvements in TD-related movements and exhibited a favorable benefit–risk profile.Short Description: Advanced age and female sex are risk factors for tardive dyskinesia (TD). This post hoc analysis assessed long-term efficacy and safety of deutetrabenazine in women who were postmenopausal who participated in an open-label extension study. Long-term (approximately 3 years) deutetrabenazine treatment provided clinically meaningful improvements in TD-related movements and exhibited a favorable benefit–risk profile.Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D, Inc.