The Food and Drug Administration has approved valbenazine capsules for the treatment of tardive dyskinesia in adults.
The approval, announced April 11, came after a 6-week, placebo-controlled trial of 234 participants that compared valbenazine to placebo. At the end of the trial, those who took valbenazine experienced improvement in the severity of involuntary movements, compared with those who received placebo. As a vesicular monoamine transporter type 2 inhibitor, valbenazine works by regulating the amount of dopamine that is released into nerve cells by blocking a protein in the brain. The drug, the first to receive approval for tardive dyskinesia in adults, will be marketed as Ingrezza by Neurocrine Biosciences. Valbenazine is reportedly being studied as a treatment for Tourette syndrome in children and adolescents.
In a statement, Mitchell Mathis, MD, director of the FDA’s division of psychiatry products in the Center for Drug Evaluation and Research, praised the approval as “an important advance for patients suffering with tardive dyskinesia.”
Characterized by uncontrolled movement of the face and body, tardive dyskinesia is a side effect in up to 8% of patients taking typical and atypical antipsychotics. The movement disorder also can cause other debilitating problems, including difficulty with chewing, speaking, and swallowing. Some data show that in about 87% of cases, the condition is irreversible even 3 years after the inciting agent has been discontinued (Parkinsonism Relat Disord. 2016. 32;124-6).
“Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,” Dr. Mathis said in the statement.
The side effects of valbenazine include sleepiness and QT prolongation. The agency said the patients taking the drug should not drive, operate heavy machinery, or engage in other potentially dangerous activities. Likewise, the drug should be avoided in patients with congenital long QT syndrome or in those with abnormal heartbeats associated with a prolonged QT interval, the agency said.
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