First drug for Tardive Dyskinesia approved by FDA

The approval for Ingrezza (valbenazine) capsules has been granted to Neurocrine Biosciences, Inc.

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The U.S. Food and Drug Administration (USFDA) approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition. The approval has been granted to Neurocrine Biosciences, Inc.
Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips. In this form of dyskinesia, the involuntary movements are tardive, meaning they have a slow or belated onset.

Tardive dyskinesia is a serious side effect sometimes seen in patients who have been treated with antipsychotic medications, especially the older medications, for long periods to treat chronic conditions, such as schizophrenia and bipolar disorder. Tardive dyskinesia can also occur in patients taking antipsychotic medications for depression and certain medications for gastrointestinal disorders and other conditions. It is unclear why some people who take these medications develop tardive dyskinesia yet others do not.

The efficacy of Ingrezza was shown in a clinical trial of 234 participants where improvement in the severity of abnormal involuntary movements was observed when compared to those who received placebo.

Ingrezza may cause serious side effects including sleepiness and heart rhythm problems (QT prolongation).

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