Tampa, FL—Pharmacists often are asked what patients can do about tardive dyskinesia, the lip smacking, tongue protrusions, and excessive eye-blinking that often accompany longer-term antipsychotic treatment.
A new option appears to be on the horizon, according to a report in the American Journal of Psychiatry. A phase III randomized, double blind, placebo-controlled trial conducted at the University of South Florida concludes that once-daily valbenazine appears to 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,” writes lead author Robert A. Hauser, MD, MBA, professor of neurology at USF. “Moreover, tardive dyskinesia symptoms often persist even after discontinuation or dosage reduction.”
The research involved 225 patients with schizophrenia, schizoaffective disorder, or a mood disorder. Results indicate that 40% of those receiving 80 mg of valbenazine, a selective vesicular monoamine transporter 2 inhibitor, improved by at least 50% compared with 8% of the group that was receiving placebo.
In the 6-week trial, participants were randomly assigned in a 1:1:1 ratio to once-daily placebo, valbenazine 40 mg/day, or valbenazine 80 mg/day. About 65% of the participants had schizophrenia or schizoaffective disorder, and 85.5% were receiving antipsychotics.
Success was determined using the Abnormal Involuntary Movement Scale (AIMS) dyskinesia score, as assessed by blinded central AIMS video raters. At the same time, safety assessments included adverse event monitoring, laboratory tests, ECG, and psychiatric measures.
“Once-daily valbenazine significantly improved tardive dyskinesia in participants with underlying schizophrenia, schizoaffective disorder, or mood disorder,” study authors conclude. “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.”
« Click here to return to Weekly News Update.