FDA Approves First Drug for Treatment of Tardive Dyskinesia
WEDNESDAY, April 12, 2017 -- Ingrezza (valbenazine), the first drug to treat adults with tardive dyskinesia, has been approved by the U.S. Food and Drug Administration.
Ingrezza's effectiveness was established in a clinical study of 234 individuals that compared the drug to a placebo. After six weeks, participants who received Ingrezza had improvement in the severity of abnormal involuntary movements.
Potential side effects included sleepiness and QT prolongation. Anyone taking Ingrezza should not drive or use heavy machinery until the effects of the drug on the person are known, the FDA warned.
"Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness," Mitchell Mathis, M.D., director of the FDA's Division of Psychiatry Products, said in a statement. "Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition."
Approval of Ingrezza was given to Neurocrine Biosciences, based in San Diego.
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Posted: April 2017