FDA OKs Deutetrabenazine (Austedo) for Tardive Dyskinesia

Megan Brooks

Disclosures

August 30, 2017

The US Food and Drug Administration (FDA) has approved deutetrabenazine (Austedo, Teva) for the treatment of tardive dyskinesia in adults.

Deutetrabenazine, a deuterated form of the vesicular monoamine transporter 2 inhibitor tetrabenazine (Xenazine, Lundbeck Inc), was approved for the treatment of chorea associated with Huntington's disease in April this year.

Tardive dyskinesia (TD) is a debilitating and often irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk, and extremities. TD affects roughly 500,000 people in the United States and is caused by certain medications used to treat psychiatric disorders or gastrointestinal conditions.

The approval of deutetrabenazine for TD was based on results from two phase 3 randomized, double-blind, placebo-controlled studies (AIM-TD and ARM-TD) that evaluated the efficacy and safety of the drug in reducing the severity of abnormal involuntary movements associated with TD.

As previously reported by Medscape Medical News, in the ARM-TD trial, which included 117 patients with TD, those who received the active drug for 12 weeks not only had greater improvement in scores on the total Abnormal Involuntary Movement Scale (AIMS) compared with those who received matching placebo (the primary endpoint), but they also had improved scores on the scale's individual components.

Results from the AIM-TD trial, which included almost 300 TD patients, showed that those who received deutetrabenazine had better quality-of-life scores on the modified 24-item Craniocervical Dystonia Questionnaire (mCDQ-24) than the placebo group.

In reporting results of the studies at the American Psychiatric Association 2017 Annual Meeting in June, Karen E. Anderson, MD, of Georgetown University, Washington, DC, told Medscape Medical News , "In both studies, we saw significant reduction in tardive dyskinesia starting as early as 2 weeks on the AIMS scale. In clinical practice, if you start patients on this drug, you could potentially see a very early response, which is incredibly encouraging."

In controlled clinical trials of patients with TD, the most common adverse reactions (4% of patients taking deutetrabenazine and more than placebo) were nasopharyngitis and insomnia.  The most common adverse reactions (>8% 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.

Deutetrabenazine may increase the risk for depression and suicidality in patients with Huntington's disease and is contraindicated in patients with Huntington's disease who are suicidal, or have untreated or inadequately treated depression.

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) or valbenazine (Ingrezza, Neurocrine Biosciences, Inc).

Deutetrabenazine may lead to a worsening in mood, cognition, rigidity, and functional capacity in patients with Huntington's disease.

Clinically relevant QT prolongation may occur in some patients treated with deutetrabenazine who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor or other drugs that are known to prolong QTc. 

Deutetrabenazine may increase the risk for akathisia, agitation, and restlessness and may cause parkinsonism in patients with Huntington's disease. Sedation is a common dose-limiting adverse reaction of deutetrabenazine.

Full prescribing information and safety information is available online.

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