A post-hoc analysis of data from a clinical trial of valbenazine (Ingrezza; Neurocrine Biosciences, Inc., San Diego, CA) has been published in the Journal of Affective Disorders. This analysis showed sustained improvement in tardive dyskinesia (TD) symptoms in patients with primary mood disorders. Valbenazine is the first treatment approved by the Food and Drug[K1] Administration (FDA) for adults with TD.
After long-term treatment with valbenazine, nearly half (46.5%) of patients had at least a 50% improvement in their Abnormal Involuntary Movement Scale (AIMS) total score from baseline. Of the patients, 60.5% had a primary diagnosis of bipolar disorder and 37.7% were diagnosed with depression or major depression. In the study, treatment with valbenazine in 40-mg and 80-mg doses significantly improved TD symptoms at week 6, with improvements sustained through week 48.
The pooled post-hoc analysis examined data from 114 patients who participated in the double-blind, placebo-controlled, 6-week phase 2 KINECT 2 study (NCT01688037) and the 6-week phase 3 KINECT 3study (NCT02274558), as well as 77 patients from the 48-weekKINECT 3 extension study(NCT02405091).
Valbenazine, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is thought to work by reducing dopamine release.
"For these patients, it is important that they are able to manage their involuntary movements while maintaining psychiatric stability with their primary mood disorder," said Roger S. McIntyre, professor of psychiatry and pharmacology at the University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network in Toronto. "The data analysis examining this patient population indicates that treatment with Ingrezza did not affect the stability of their underlying psychiatric disorder and significantly improves the severity of tardive dyskinesia."