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FDA Approves Austedo XR Extended-Release Tablets for Huntington’s Disease

FDA Approves Austedo XR Extended-Release Tablets for Huntington’s Disease

The FDA approved deutetrabenazine extended-release tablets (Austedo XR, Teva Pharmaceuticals) for adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (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,” Eric Hughes, MD, PhD, the executive vice president of research and development and chief medical officer at Teva, said in a press release. 

The approval was based on data demonstrating that the once-daily deutetrabenazine formulation is therapeutically equivalent to the currently marketed twice-daily option, the company said. The new once-daily regimen will be available in 6-, 12- and 24-mg tablet strengths. Teva expects deutetrabenazine extended-release tablets to be available in the United States later this year. Deutetrabenazine is the only vesicular monoamine transporter 2 inhibitor with three-year long-term data for TD and HD chorea (CNS Drugs 2022;36[11]:1207-1216; Front Neurol 2022;13:773999).

“Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets,” Teva said in its press release. During clinical trials for deutetrabenazine, the most common adverse reactions in patients with HD and TD were, respectively, somnolence (11%), diarrhea (9%), dry mouth (9%) and fatigue (9%); and nasopharyngitis (4%) and insomnia (4%). A boxed warning cautions that the medications can increase the risk for depression and suicidal thoughts and behavior in patients with HD; both formulations of deutetrabenazine are contraindicated in patients who are suicidal or have untreated or inadequately treated depression. 

FEBRUARY 24, 2023


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