First Treatment for Tardive Dyskinesia Approved in US

Wednesday, April 12, 2017 | FDA Approval/Clearance , Movement Disorders , Product Launches and Updates


The FDA approved the selective VMAT2 inhibitor Ingrezza (valbenazine, Neurocrine Biosciences), making it the first treatment approved in the US to treat adults with tardive dyskinesia. The efficacy of Ingrezza was shown in a clinical trial of 234 participants that compared Ingrezza to placebo. After six weeks, participants who received Ingrezza had improvement in the severity of abnormal involuntary movements compared to those who received placebo. Adverse events of Ingrezza include sleepiness and heart rhythm problems. Its use should be avoided in patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval.

Tardive dyskinesia is sometimes seen in patients who have been treated with antipsychotic medications for long periods to treat chronic conditions, such as schizophrenia and bipolar disorder. It can also occur in patients taking antipsychotic medications for depression and certain medications for gastrointestinal disorders and other conditions. 

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