The FDA has approved an additional indication for deutetrabenazine (Austedo, Teva Pharmaceutical Industries) that allows its use for the treatment of tardive dyskinesia in adults. The drug was previously approved for the treatment of chorea associated with Huntington’s disease in April 2017.
Tardive dyskinesia is a debilitating and often irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk, and extremities. The condition affects about 500,000 people in the United States and can be caused by certain medications used to treat mental health conditions or gastrointestinal conditions.
The approval was based on results from two phase 3 randomized, double-blind, placebo-controlled, parallel-group studies assessing the efficacy and safety of deutetrabenazine in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia.
Deutetrabenazine carries a boxed warning: it can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. The drug is also contraindicated in patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine, Valeant) or valbenazine (Ingrezza, Neurocrine Biosciences).
The most common adverse reactions (4% of deutetrabenazine-treated patients and greater than placebo) in controlled clinical studies of patients with tardive dyskinesia were nasopharyngitis and insomnia. The most common adverse reactions (8% or greater of deutetrabenazine-treated patients and greater than placebo) in a controlled clinical study of patients with chorea associated with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue.
Source: Business Wire; August 30, 2017.