Valbenazine, administered once daily, can significantly reduce tardive dyskinesia in patients with schizophrenia, schizoaffective disorder and mood disorder, found a University of South Florida study.
Antipsychotic treatment can cause involuntary movements such as lip smacking, tongue protrusions and excessive eye blinking. These movements typically occur after more than 3 months of treatment and are called tardive dyskinesia.
Dr Robert A Hauser, professor of neurology at the University of South Florida in Tampa, is the lead author of a study that concludes valbenazine administered once daily can significantly reduce tardive dyskinesia in patients with schizophrenia, schizoaffective disorder and mood disorder.
"One approach to managing tardive dyskinesia is to discontinue antipsychotic treatment or reduce the dosage, but these options are not always feasible, because withdrawal can exacerbate tardive dyskinesia symptoms or have a negative impact on psychiatric status. Moreover, tardive dyskinesia symptoms often persist even after discontinuation or dosage reduction," wrote Hauser, who directs the Parkinson's Disease and Movement Disorders Centre at USF.
Valbenazine is a selective vesicular monoamine transporter 2 inhibitor. Two hundred twenty-five people with schizophrenia, schizoaffective disorder or a mood disorder participated in the phase 3 randomized double blind, placebo-controlled trial. The study found 40% of those who received valbenazine 80mg/day improved by at least 50%. That's compared to just 8% in the placebo group.
Researchers also determined that valbenazine was well tolerated. Drowsiness, restlessness and dry mouth were reported as adverse effects.
Abstract
Objective: Tardive dyskinesia is a persistent movement disorder induced by dopamine receptor blockers, including antipsychotics. Valbenazine (NBI-98854) is a novel, highly selective vesicular monoamine transporter 2 inhibitor that demonstrated favorable efficacy and tolerability in the treatment of tardive dyskinesia in phase 2 studies. This phase 3 study further evaluated the efficacy, safety, and tolerability of valbenazine as a treatment for tardive dyskinesia.
Method: This 6-week, randomized, double-blind, placebo-controlled trial included patients with schizophrenia, schizoaffective disorder, or a mood disorder who had moderate or severe tardive dyskinesia. Participants were randomly assigned in a 1:1:1 ratio to once-daily placebo, valbenazine at 40 mg/day, or valbenazine at 80 mg/day. The primary efficacy endpoint was change from baseline to week 6 in the 80 mg/day group compared with the placebo group on the Abnormal Involuntary Movement Scale (AIMS) dyskinesia score (items 1–7), as assessed by blinded central AIMS video raters. Safety assessments included adverse event monitoring, laboratory tests, ECG, and psychiatric measures.
Results: The intent-to-treat population included 225 participants, of whom 205 completed the study. Approximately 65% of participants had schizophrenia or schizoaffective disorder, and 85.5% were receiving concomitant antipsychotics. Least squares mean change from baseline to week 6 in AIMS dyskinesia score was −3.2 for the 80 mg/day group, compared with −0.1 for the placebo group, a significant difference. AIMS dyskinesia score was also reduced in the 40 mg/day group (−1.9 compared with −0.1). The incidence of adverse events was consistent with previous studies.
Conclusions: Once-daily valbenazine significantly improved tardive dyskinesia in participants with underlying schizophrenia, schizoaffective disorder, or mood disorder. Valbenazine was generally well tolerated, and psychiatric status remained stable. Longer trials are necessary to understand the long-term effects of valbenazine in patients with tardive dyskinesia.
Authors
Robert A Hauser, Stewart A Factor, Stephen R Marder, Mary Ann Knesevich, Paul M Ramirez, Roland Jimenez, Joshua Burke, Grace S Liang, Christopher F O’Brien
[link url="https://www.sciencedaily.com/releases/2017/04/170407160154.htm"]University of South Florida Health material[/link]
[link url="http://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.2017.16091037"]American Journal of Psychiatry abstract[/link]