A long-term, open-label study of valbenazine for tardive dyskinesia

• Published in: CNS spectrums 2021-08, Vol.26 (4), p.345-353
• Main Authors: Lindenmayer, Jean-Pierre, Verghese, Cherian, Marder, Stephen R., Burke, Joshua, Jimenez, Roland, Siegert, Scott, Liang, Grace S., O’Brien, Christopher F.
• Format: Article
• Language: English
• Subjects: Adrenergic Uptake Inhibitors - therapeutic use; Aged; Antipsychotics; Consent; Dopamine; Double-Blind Method; Dyskinesia; FDA approval; Female; Humans; Male; Mental disorders; Metabolites; Middle Aged; Original Research; Pathophysiology; Patient Satisfaction; Psychotropic drugs; Tardive Dyskinesia - drug therapy; Tetrabenazine - analogs & derivatives; Tetrabenazine - therapeutic use; Treatment Outcome; Valine - analogs & derivatives; Valine - therapeutic use
• ISSN: 1092-8529; 2165-6509
• DOI: 10.1017/S109285292000108X

Individuals with tardive dyskinesia (TD) who completed a long-term study (KINECT 3 or KINECT 4) of valbenazine (40 or 80 mg/day, once-daily for up to 48 weeks followed by 4-week washout) were enrolled in a subsequent study (NCT02736955) that was primarily designed to further evaluate the long-term safety of valbenazine. Participants were initiated at 40 mg/day (following prior valbenazine washout). At week 4, dosing was escalated to 80 mg/day based on tolerability and clinical assessment of TD; reduction to 40 mg/day was allowed for tolerability. The study was planned for 72 weeks or until termination due to commercial availability of valbenazine. Assessments included the Clinical Global Impression of Severity-TD (CGIS-TD), Patient Satisfaction Questionnaire (PSQ), and treatment-emergent adverse events (TEAEs). At study termination, 85.7% (138/161) of participants were still active. Four participants had reached week 60, and none reached week 72. The percentage of participants with a CGIS-TD score ≤2 (normal/not ill or borderline ill) increased from study baseline (14.5% [23/159]) to week 48 (64.3% [36/56]). At baseline, 98.8% (158/160) of participants rated their prior valbenazine experience with a PSQ score ≤2 (very satisfied or somewhat satisfied). At week 48, 98.2% (55/56) remained satisfied. Before week 4 (dose escalation), 9.4% of participants had ≥1 TEAE. After week 4, the TEAE incidence was 49.0%. No TEAE occurred in ≥5% of participants during treatment (before or after week 4). Valbenazine was well-tolerated and persistent improvements in TD were found in adults who received once-daily treatment for >1 year.