Valbenazine Eases TD Symptoms in Mood Disorder Patients
Once-daily valbenazine significantly reduced involuntary movements associated with tardive dyskinesia in patients with primary mood disorders, at both 6 weeks and 48 weeks after beginning the treatment, according to a post-hoc analysis published online in the Journal of Affective Disorders.
The US Food and Drug Administration approved valbenazine (Ingrezza) for the treatment of tardive dyskinesia in April 2017.
“Patients with mood disorders, such as bipolar and major depression, are typically high functioning and the abnormal movements associated with their tardive dyskinesia can be burdensome and lead to social isolation. 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, a psychiatry and pharmacology professor at the University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network in Toronto, Ontario, Canada.
“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.”
The analysis pooled data from a pair of 6-week double-blind placebo-controlled trials involving 114 patients with bipolar disorder, depression, or major depression and a long-term blinded extension study involving 77 patients. Treatment with valbenazine at both 40-mg and 80-mg doses, it showed, significantly improved tardive dyskinesia symptoms at week 6. Those improvements were sustained through week 48.
Specifically, researchers identified significant improvement in Abnormal Involuntary Movement Scale (AIMS) scores among patients treated with valbenazine, compared with those treated with placebo (40 mg/day, -3.1; 80 mg/day, -3.5; placebo, -0.09). Gains from baseline were sustained through week 48 (40 mg/day, -4.2; 80 mg/day, -5.8). After long-term treatment, 46.5% of patients had at least a 50% improvement in AIMS total scores from baseline.
Valbenazine was generally well tolerated, researchers reported, and patients had no notable worsening of psychiatric symptoms. The only treatment-emergent adverse event reported in 10% or more of patients treated with valbenazine was somnolence (11.4%). In the long-term extension study, the only treatment-emergent adverse event reported in 10% or more patients of was headache (10.4%).
McIntyre RS, Calabrese JR, Nierenberg AA, et al. The effects of valbenazine on tardive dyskinesia in patients with a primary mood disorder. Journal of Affective Disorders. 2018 December 17;[Epub ahead of print].
New Ingrezza (valbenazine) analysis published in the journal of affective disorders demonstrates sustained improvement in tardive dyskinesia symptoms in patients with primary mood disorders [press release]. San Diego, California: Neurocrine Biosciences; January 16, 2019.