Treatment Effect Sizes of Once-Daily Valbenazine for Tardive Dyskinesia and for Chorea Associated with Huntington’s Disease: Post-Hoc Analyses of Two Phase 3 Clinical Trials

Abstract: Once-daily valbenazine is approved for the treatment of tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). Valbenazine effect sizes (Cohen’s d) for these movement disorders were calculated using primary endpoint data from the phase 3 trials of TD (KINECT® 3: NCT02274558) and HD-chorea (KINECT®-HD: NCT04102579). KINECT 3 was a 6-week, fixed-dose study (valbenazine 40 or 80 mg) with the primary endpoint defined as the change from baseline to Wk6 in the Abnormal Involuntary Movement Scale (AIMS) total score, as assessed by central video raters blinded to both treatment and visit. The least-squares mean difference (LSMD) between treatment groups indicated greater AIMS improvement with valbenazine versus placebo for 80 mg (-3.1, PShort Description: Valbenazine, a potent and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for the treatment of adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). Primary endpoint data from two phase 3 trials, KINECT® 3 and KINECT®-HD, were analyzed post hoc to assess treatment effect sizes (Cohen’s d) for TD and HD chorea. Results of these analyses indicate robust efficacy with once-daily valbenazine for both movement disorders.Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.