Wednesday, April 12, 2017

FDA Approves First Medication to Treat Tardive Dyskinesia

The Food and Drug Administration on Tuesday announced it approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia (TD)—a serious side effect associated with chronic use of antipsychotics. Ingrezza, a novel and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first and only FDA-approved product for this condition.

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

The approval of the medication was based in part on the results of a study recently published in AJP in Advance, which compared changes in involuntary movements in patients with moderate-to-severe TD who took valbenazine (40 mg/day or 80 mg/day) or with those taking placebo daily for six weeks. Approximately 65% of participants had schizophrenia or schizoaffective disorder, and 85.5% were receiving concomitant antipsychotics.

The authors found that treatment with valbenazine resulted in a significant reduction in patients’ Abnormal Involuntary Movement Scale (AIMS) dyskinesia score compared with placebo. The percentage of participants who achieved at least a 50% reduction in AIMS was 40 percent (p<0.001) in participants receiving 80 mg/day of Ingrezza compared with only 8.7% of those who received placebo.

The FDA announcement described several side effects that could arise from taking the medication: “Ingrezza may cause serious side effects including sleepiness and heart rhythm problems (QT prolongation). Its use should be avoided in patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval. Those taking Ingrezza should not drive or operate heavy machinery or do other dangerous activities until it is known how the drug affects them.”

The medication could be available through a select pharmacy network as early as next week, according to a press release by Neurocrine Biosciences, the developer of Ingrezza. Additional prescribing information is posted here.

For more information, see the Psychiatric News PsychoPharm article “New Hope for Patients With Tardive Dyskinesia” by Stanley N. Caroff, M.D.


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