FDA Approves New Treatment for Tardive Dyskinesia

The US Food and Drug Administration has recently approved Austedo (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adult patients. This approval extends the indication of Austedo, which was previously approved in April for the treatment of chorea in patients with Huntington disease.

Approval for the new indication was based on results from 2 phase-III randomized controlled trials, which demonstrated the drug’s safety and efficacy in reducing the severity of abnormal involuntary movements in patients with tardive dyskinesia.

Common adverse effects associated with Austedo include nasopharyngitis and insomnia. Austedo was also associated with an increased risk of depression and suicidality in patients with Huntington disease.

—Melissa Weiss

Reference:
Teva announces FDA approval of AUSTEDO® (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults [press release]. Jerusalem, IL: Teva Pharmaceutical Industries Ltd; August 30, 2017. http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2297469. Accessed September 1, 2017.