Ingrezza (valbenazine), the first drug to treat adults with the neurological disorder tardive dyskinesia, has been approved by the U.S. Food and Drug Administration.
The disorder is characterized 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.
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 can be disabling and can further stigmatize 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.”
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.
Approval of Ingrezza was given to Neurocrine Biosciences, based in San Diego.
To learn more, visit the FDA.
SOURCE: April 11, 2017, news release, U.S. Food and Drug Administration