FDA Approves First Drug to Treat Tardive Dyskinesia

The FDA approved valbenazine (Ingrezza) for the treatment of tardive dyskinesia, a neurological disorder that results in involuntary movements.

Tardive dyskinesia is a serious adverse event (AE) of antipsychotic medications that can develop in some patients. It usually effects the jaw, lips, and tongue, and involves involuntary movements such as smacking of the lips, sticking out the tongue, and grimacing.

The approval was based on a clinical trial that examined the efficacy of valbenazine compared with placebo in 234 patients with tardive dyskinesia, according to apress release.

After 6 weeks, the study results showed that patients who received valbenazine saw improvement in the severity of abnormal involuntary movements compared with patients in the placebo arm.

“Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,” Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition.”

Valbenazinemay cause serious AEs, including sleepiness and heart rhythm problems (QT prolongation). Patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval should avoid the use of valbenazine.

Patients taking valbenazine should not drive or operate heavy machinery or engage in other dangerous activities until it is known how the drug affects them, according to the release.