Ingrezza (valbenazine), the first drug to treat adults with the neurological disorder tardive dyskinesia, has been approved by the US Food and Drug Administration. Approval was given to Neurocrine Biosciences, based in San Diego.
The disorder may be a side effect of older antipsychotic medications to treat conditions such as schizophrenia, depression or bipolar disorder. It's not known why some users of these medications develop tardive dyskinesia, while others don't, the agency said.
Tardive dyskinesia is characterised by repetitive involuntary movements, usually of the jaw, lips and tongue. Affected people may stick out the tongue, smack the lips, involuntarily move the arms and legs, and have trouble breathing, the FDA said in a news release.
Careful monitoring needed
Ingrezza's effectiveness was established in a clinical study of 224 people that compared the drug to a placebo. Potential side effects included sleepiness and abnormal heartbeat. Anyone taking Ingrezza should not drive or use heavy machinery until the effects of the drug on the person are known, the FDA warned.
But options available for the management of tardive dyskinesia are limited, according to scientists in Richmond, Virginia. Careful monitoring needs to be employed for the management of the movement disorder.
"Tardive dyskinesia can be disabling and can further stigmatise patients with mental illness," said Dr Mitchell Mathis, director of the FDA's Division of Psychiatry Products. "Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition."
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