FDA approves new doses of Austedo XR for tardive dyskinesia, Huntington’s chorea
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Key takeaways:
- The new once-daily tablet strength doses are 30 mg, 36 mg, 42 mg and 48 mg.
- Symptom improvement in tardive dyskinesia may occur as early as 2 weeks.
The FDA has approved Austedo XR in four new tablet strengths for adults diagnosed with tardive dyskinesia and chorea associated with Huntington’s disease, according to the manufacturer.
In a press release, Teva Pharmaceuticals revealed that the latest approval allows for one-pill, once-daily administration in doses of 30 mg, 36 mg, 42 mg and 48 mg, adding to the previously FDA-approved strengths of 6 mg, 12 mg and 24 mg.
The first vesicular monoamine transporter 2 inhibitor (VMAT2) to receive FDA approval for adults, safety and efficacy results have not yet been established for Austedo XR (deutetrabenazine) in pediatric populations.
“The FDA approval of Austedo XR as a one pill, once daily option across clinically therapeutic doses, provides patients with an important new treatment option that can be safely integrated into existing disease management plans,” Rakesh Jain, MD, MPH, clinical professor of psychiatry at Texas Tech University School of Medicine, told Healio in an email.
Individuals with tardive dyskinesia prescribed Austedo XR may experience improvement in their symptoms as soon as 2 weeks, while those with Huntington’s chorea may experience a significant reduction in Total Maximal Chorea (TMC) score, stemming from data culled from 3 years of clinical trials in patients with both conditions, according to the release.
Austedo XR, along with its twice-daily counterpart, Austedo, are the only VMAT2 inhibitor treatments that carry no restrictions with CYP3A4/5 inducers or inhibitors for individuals who take other medications to manage underlying conditions.
“Since our launch of Austedo in 2017, we have been committed to helping people living with [tardive dyskinesia] and [Huntington’s disease] chorea treat these chronic, involuntary movements,” Dell Faulkingham, senior vice president and head of U.S. Innovative Medicines at Teva, said in the release. “This latest milestone offers a streamlined treatment regimen for clinically therapeutic doses with the broadest dosing flexibility.”