The U.S. Food and Drug Administration (FDA) said Tuesday it approved Ingrezza (valbenazine) capsules to treat patients with tardive dyskinesia, making it the first drug recognized for this disease.

Tardive dyskinesia is a neurological disorder marked by repetitive, involuntary movements, such as grimacing, sticking out the tongue and smacking the lips, according to its press release. Rapid involuntary movements of the limbs, torso, and fingers may also occur. Respiratory irregularity such as grunting and difficulty breathing is another symptom.

"Tardive dyskinesia can be disabling and further stigmatize patients with mental illness," said Mitchell Mathis, a director in the FDA’s Center for Drug Evaluation and Research. "Approving the first drug for treating tardive dyskinesia is a significant advance for patients suffering from this condition."

Tardive dyskinesia is a serious side effect from patients who are treated with antipsychotic medications with chronic diseases such as schizophrenia and bipolar disorder who are treated with antipsychotic drugs for many years.

Ingrezza showed its efficacy in a clinical trial of 234 participants that compared Ingrezza to placebo (a substance or treatment with no active therapeutic effect). After six weeks, participants who received Ingrezza showed improvement in their abnormal involuntary movements compared with those who received placebo.

However, Ingrezza can cause serious side effects, including sleepiness and heart rhythm problems. Patients with congenital long QT syndrome or with an abnormal heartbeat should avoid taking Ingrezza.

Patients taking the drug should not drive or operate heavy machinery until it is known how the drug personally affects them.