HealthDay News — The US Food and Drug Administration has approved Ingrezza (valbenazine), which is the first drug to treat adults with tardive dyskinesia.
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, MD, 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.
FDA Approves First Drug to Treat Tardive Dyskinesia [press release]. Silver Spring, MD: US Food and Drug Administration; April 11, 2017.