FDA Approves Extended Release Deutetrabenazine for Tardive Dyskinesia, Chorea Associated With Huntington Disease

The FDA has approved extended-release deutetrabenazine (Austedo XR; Teva Pharmaceutical Industries Ltd.) tablets as a once-daily formulation of the currently marketed twice-daily Austedo for adult patients with tardive dyskinesia (TD) and chorea associated with Huntington disease (HD).

Deutetrabenazine is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the FDA for the treatment of TD in adults and for the treatment of chorea associated with HD.

“For some patients living with TD and HD, treatment adherence can be a challenge that this new once-daily dosing option can help to address,” said Eric Hughes, MD, PhD, Executive Vice President of R&D and chief medical officer at Teva, in a press release.

The once-daily formulation of deutetrabenazine demonstrated therapeutic equivalency to the twice-daily formulation of the drug, according to Teva. Austedo XR will be available in 3 extended-release tablet strengths—6 mg, 12 mg, and 24 mg. The drug can be taken with or without food. Teva said the new tablet strengths provide an updated regimen that may result in a lower pill count for patients compared to the twice-daily formulation of deutetrabenazine.

TD is an involuntary movement disorder in which patients may experience uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts. TD is caused by chronic use of dopamine receptor-blocking drugs, also known as neuroleptics.

Individuals with TD typically experience involuntary and abnormal movements of different muscles and the tongue, lips, or jaw. It has been estimated that between 20% and 50% of all patients treated with chronic neuroleptic therapy will develop TD, with prevalence increasing with advanced age. Since there is no cure available for TD, prevention is critical.

In recent years, prescribing of antipsychotics has been increasing at a steady rate. Although the introduction of atypical antipsychotics has helped limit the risk of extrapyramidal symptoms, TD remains a concern among treated patients. Because TD is irreversible, physicians often focus on prevention and decreasing antipsychotic doses when symptoms begin.

HD is a fatal neurodegenerative disease that involves uncoordinated and uncontrollable movements, cognitive deterioration, and behavioral and/or psychological problems. Chorea, which involves involuntary, random, and sudden twisting and writhing movements, is among the more striking physical signs of HD, occurring in approximately 90% of patients. The condition can significantly affect daily activities and progressively limit the lives of patients. The safety and efficacy of deutetrabenazine in pediatric patients have not been established.

Austedo is contraindicated and includes a boxed warning in patients who are suicidal or patients with untreated or inadequately treated depression, as the drug can increase the risk of depression and suicidal thoughts and behaviors in patients with HD. It is also contraindicated in patients with hepatic impairment, patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy, patients taking reserpine or within 20 days of discontinuing reserpine, and patients taking tetrabenazine (Xenazine).

Adverse effects include possible worsening in mood, cognition, rigidity, and functional capacity. Austedo may also increase the risk of akathisia, agitation, and restlessness, and can cause parkinsonism in patients with HD.

“[The] approval marks an exciting milestone for patients with TD and HD chorea,” said Sven Dethlefs, PhD, executive vice president, North America Commercial at Teva, said in a press release.

Austedo XR is expected to be available in the United States later this year, according to Teva.

Reference

Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, a New Once-Daily Formulation of AUSTEDO® (deutetrabenazine) Tablets. News release. Teva Pharmaceuticals. Accessed February 20, 2023. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-fda-approval-of-austedo-xr-deutetrabenazine-extended-release-tablets-a-new-once-daily-/