The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of tardive dyskinesia in adults, according to an announcement from Teva Pharmaceutical Industries.
The agency’s approval of Austedo was based on results from two phase 3 clinical trials in which the drug was shown to be safe and effective at reducing involuntary movements collectively termed tardive dyskinesia, a debilitating and sometimes irreversible movement disorder which affects about 500,000 people in the United States. Austedo was first approved in April 2017 to treat chorea associated with Huntington’s disease.
The most common side effects of Austedo in tardive dyskinesia patients are nasopharyngitis and insomnia. People who have hepatic impairment, are taking tetrabenazine (Xenazine) or valbenazine (Ingrezza), or are taking or have recently taken monoamine oxidase inhibitors or reserpine should not be prescribed Austedo.
“Physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition,” Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva, said in the announcement.
The full prescribing information can be viewed here .