Once-daily valbenazine, a selective vesicular monoamine transporter 2 inhibitor, significantly improved tardive dyskinesia in individuals with schizophrenia, schizoaffective disorder or 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,” Robert A. Hauser, MD, MBA, of University of South Florida in Tampa, and colleagues wrote. “Moreover, tardive dyskinesia symptoms often persist even after discontinuation or dosage reduction.”
To assess efficacy, safety and tolerability of valbenazine for tardive dyskinesia, researchers conducted a phase 3, randomized, double-blind, placebo-controlled trial among an intent-to-treat population of 225 individuals with schizophrenia, schizoaffective disorder or a mood disorder with moderate or severe tardive dyskinesia. Study participants were randomly assigned to receive 40 mg or 80 mg of valbenazine per day or placebo.
Overall, an estimated 65% of participants had schizophrenia or schizoaffective disorder and 85.5% were receiving concomitant antipsychotics.
From baseline to week 6, least squares mean change in Abnormal Involuntary Movement Scale (AIMS) dyskinesia scores was –3.2 for participants who received 80 mg of valbenazine and –1.9 for those who received 40 mg, compared with –0.1 for placebo.
The most common treatment-emergent adverse events among both dosages of valbenazine were somnolence, akathisia and dry mouth.
“Once-daily treatment with valbenazine at 80 mg/day significantly improved tardive dyskinesia compared with placebo in a population of patients with schizophrenia, schizoaffective disorder, or a mood disorder. Both valbenazine dosages were generally well tolerated, even as participants were taking a wide range of concomitant medications,” the researchers wrote. “Psychiatric status in these patients, based on reported rates of adverse events and specific psychiatric scales, remained stable.” – by Amanda Oldt
Disclosure: Hauser reports consultant roles with AbbVie, Allergan, Auspex, Cowan Group, Eli Lilly, Gerson Lehrman Group, GuidePoint Global, Impax Laboratories, Lundbeck, the Michael J. Fox Foundation, Neurocrine Biosciences, Teva, and UCB Biosciences; as a speaker for Biotie Therapies, Novartis, Teva, and UCB Biosciences; on advisory boards for Acadia Pharmaceuticals, Acorda Therapeutics, AstraZeneca, Biotie Therapies, Cynapsus Therapeutics, Lundbeck, Neurocrine Biosciences, Pfizer, and US WorldMeds; and on the steering committee for Chelsea Therapeutics. Please see the study for a full list of relevant financial disclosures.