Long-Term Safety and Tolerability of Once-Daily Valbenazine in Patients With Tardive Dyskinesia

Objective: To evaluate the long-term safety and tolerability of once-daily valbenazine in adults with tardive dyskinesia (TD).

Methods: Completers from 2 long-term studies (KINECT 3 [NCT02274558], KINECT 4 [NCT02405091]) could enroll in a rollover study (NCT02736955). Safety data from KINECT 3/4 (pooled) and the rollover study were analyzed descriptively; valbenazine doses were pooled for analysis. Treatment-emergent adverse events (TEAEs) were assessed for all participants. Psychiatric status was assessed in KINECT 3/4 using: Positive and Negative Syndrome Scale (PANSS) and Calgary Depression Scale for Schizophrenia (CDSS) (schizophrenia/schizoaffective disorder participants); Montgomery-Åsberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) (mood disorder participants).

Results: Analyses included 304 KINECT 3/4 participants and 160 rollover participants. The KINECT 3/4, summary of TEAEs was: any TEAE (71.7%), serious TEAE (16.8%), discontinuation due to TEAE (15.5%). The 3 most common TEAEs in KINECT 3/4 were headache (8.9%), urinary tract infection (8.9%), and somnolence (7.9%). The rollover summary of TEAEs was: any TEAE (53.1%), serious TEAE (10.0%), and discontinuation due to TEAE (5.6%). The most common rollover TEAEs were back pain (4.4%) and urinary tract infection (4.4%). Psychiatric status generally remained stable long-term in KINECT 3/4, as indicated by mean changes from baseline to Week 48 (PANSS total,-3.2; CDSS,-0.5; MADRS,0.3; YMRS,-1.0).

Conclusions: Valbenazine appeared to be well tolerated with no unexpected safety signals in adults who received >1 year of once-daily treatment. Psychiatric stability was generally maintained in schizophrenia/schizoaffective and mood disorder participants. Once-daily valbenazine may be an appropriate treatment for the long-term management of TD.