New Drug Eases Tardive Dyskinesia in Pivotal Trial

VANCOUVER – Individuals experiencing movement disorders of the face and limbs caused by antipsychotic drugs got substantial relief from the investigational agent valbenazine, researchers reported here.

In a phase III, randomized clinical trial, patients on an 80-mg dose of valbenazine achieved a 3.2-point reduction in the Abnormal Involuntary Movement Scale (AIMS) compared with a 0.1-point reduction in the scale which measures tremors among patients who were assigned assigned to placebo (P<0.0001), said Robert Hauser, MD, of the University of South Florida Morsani College of Medicine.

At the annual meeting of the American Academy of Neurology, Hauser reported that patients on a 40-mg dose also achieved a statistically significant reduction in AIMS scores – 1.9 points (P=0.0021). The mean baseline score on the AIMS scale was 10.

For a secondary endpoint, the Clinicians Global Index of Change-Tardive Dyskinesia (CGI-TD), patients on treatment with the higher dose showed a trend to improvement (P=0.0560) as did patients on the lower dose of the drug (P=0.0742).

“Once-daily valbenazine improved tardive dyskinesia severity,” Hauser told MedPage Today. “Treatment with valbenazine was well tolerated, with no notable safety issues.”


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