The FDA has approved the first drug for the treatment of adults with tardive dyskinesia, Ingrezza (valbenazine) capsules.
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Tardive dyskinesia is a neurological disorder that is characterised by involuntary movements, usually of the jaw, lips and tongue, and can sometimes cause involuntary movement of extremities or difficulty breathing. This condition is also a serious side effect that is sometimes encountered in patients being treated with antipsychotic medications. Additionally, it can occur in patients taking antipsychotic medications for depression and certain medications for gastrointestinal disorders and other conditions.
Dr Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, commented, “Tardive dyskinesia can be disabling and can further stigmatise patients with mental illness. Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition.”
Ingrezza demonstrated efficacy when compared with placebo in a clinical trial of 234 participants. The study demonstrated that patients receiving the drug encountered an improvement in the severity of abnormal movements at six weeks.