FDA Approves Deutetrabenazine Once-Daily Extended-Release Tablets to Treat TD and HD Chorea

Updated on May 30, 2024, at 12 pm.

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The FDA has approved deutetrabenazine (Austedo XR; Teva Pharmaceuticals) as an oral, once daily, extended-release treatment option indicated for adults with tardive dyskinesia (TD) and Huntington disease (HD) chorea. The treatment now has 4 different doses, including 30-, 36-, 42-, and 48-mg tablets.¹

Deutetrabenazine is a highly selective, deuterium containing VMAT2 inhibitor that has the same chemical structure as tetrabenazine; however, the molecule is formed with 6 sites that contain deuterium—which prolongs the 9- to 10-hour half-life of the drug and reduces variability—instead of hydrogen. Additionally, deutetrabenazine is metabolized in the liver to α-dihydrodeutetrabenazine and β-dihydrodeutetrabenazine, and the 2 metabolites are activated and act by reversibly inhibiting VMAT2. Before the approval of the extended-release, 1-pill, once daily tablets, deutetrabenazine was typically administered twice per day in 3 different strengths, 6-, 9-, and 12-mg tablets, but the recommended starting dose was 6 mg daily, with a max dose of 24 mg twice per day.²

Approximately 1 in 4 American citizens experience the onset of TD as a result of them taking certain medications for mental health. TD is a chronic movement disorder—one that is often overlooked—that can have emotional, physical, and psychological impacts on patients. Additionally, HD is a neurodegenerative disease that is fatal, and is characterized by cognitive deterioration, behavior, and/or psychological problems as well as uncoordinated or uncontrollable movements known as chorea. This symptom affects approximately 90% of patients. Both TD and chorea-associated HD can create significant challenges to patients’ day-to-day lives and impact everyday tasks such as talking, eating, and walking.¹

“Knowing patients living with TD and HD chorea are also managing other underlying concomitant conditions, it is important that treatment options for these chronic movement disorders are not only effective, but keep the patient experience in mind,” said Rakesh Jain, MD, MPH, clinical professor of psychiatry at Texas Tech University School of Medicine, in a news release. “This latest [deutetrabenazine] approval provides patients with the same proven efficacy, but now with the convenience of a 1 pill, once daily option for clinically therapeutic doses as established by the pivotal clinical trials to help control involuntary movements that can make carrying out basic daily activities difficult."¹

According to 4 clinical trials, deutetrabenazine was observed to be effective in the treatment of HD-related chorea, with both short- and long-term favorable side effect profiles. The treatment was also shown to significantly improve TD and was generally well-tolerated; however, long-term safety and efficacy must be assessed further because of the high attrition rate in the long-term follow-up studies. Further, in long-term follow-up studies, overall safety and continued efficacy were confirmed, with indirect comparisons revealing that deutretrabenazine may be superior to tetrabenazine, but direct comparisons of safety and efficacy between the 2 drugs are lacking. The investigators noted that when treating TD and chorea in HD, doses up to 72 mg per day for up to 3 years in duration were tolerable by patients.²

“Since our launch of [deutetrabenazine] in 2017, we have been committed to helping people living with TD and HD chorea treat these chronic, involuntary movements,” said Dell Faulkingham, senior vice president and head of US Innovative Medicines at Teva, said in the news release. “[Deutetrabenazine], backed by the longest efficacy and tolerability data to date, has continued to evolve—having received approval for [deutetrabenazine], our once daily extended-release formulation in February 2023. This latest milestone offers a streamlined treatment regimen for clinically therapeutic doses with the broadest dosing flexibility.”¹

Reference

1. Teva Pharmaceuticals. Teva Announces AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets Now U.S. FDA Approved as a One Pill, Once-Daily Treatment Option for Clinically Therapeutic Doses (24–48 mg/day). News release. May 29, 2024. Accessed May 30, 2024. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-austedo-xr-deutetrabenazine-extended-release-tablets-now-u.s.-fda-approved-as-a-one-pil/

2. Frank, S, Alakkas, A. Clinical Utility of Deutetrabenazine as a Treatment Option for Chorea Associated with Huntington's Disease and Tardive Dyskinesia. Ther Clin Risk Manag. 2023;19:1019-1024. Published 2023 Dec 1. doi:10.2147/TCRM.S279332