The FDA has approved valbenazine (Ingrezza, Neurocrine Biosciences Inc.) capsules, the first drug approved to treat adults with tardive dyskinesia.
Tardive dyskinesia, a neurological condition, is characterized by repetitive involuntary movements, usually of the jaw, lips, and tongue. Some individuals also experience involuntary movement of the extremities and difficulty breathing.
Tardive dyskinesia can also be a serious adverse effect seen in patients taking antipsychotic medications for long periods to treat chronic conditions, such as schizophrenia or bipolar disorder. It can also occur in patients taking medications for depression and certain medication for gastrointestinal disorders.
The approval is based on a clinical trial of 234 participants that demonstrated Ingrezza’s efficacy compared to a placebo. Patients who received Ingrezza experienced an improvement in the severity of abnormal involuntary movements after 6 weeks compared to those who received a placebo.
Some adverse effects associated with Ingrezza include sleepiness and heart rhythm problems (QT prolongation).
The application was previously granted Fast Track, Priority Review, and Breakthrough Therapy designations.
FDA approves first drug to treat tardive dyskinesia [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552418.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
. Accessed April 12, 2017.