Austedo XR, a Once-Daily Formulation of Deutetrabenazine, Gets FDA Approval

The Food and Drug Administration (FDA) has approved Austedo^® XR, a new once-daily formulation of deutetrabenazine, for the treatment of adults with tardive dyskinesia and chorea associated with Huntington disease.

Austedo XR is a vesicular monoamine transporter 2 inhibitor. Because the once-daily formulation has been shown to be therapeutically equivalent to the twice-daily formulation, the same total daily dosage can be used when switching between Austedo (twice daily) tablets and Austedo XR (once daily) tablets. Unlike Austedo (twice daily) tablets, which should be administered with food, the new once-daily formulation can be administered with or without food.

“The approval of Austedo XR is a reflection of our ongoing innovation for people living with TD and HD chorea,” said Eric Hughes, MD, PhD, Executive Vice President of R&D and Chief Medical Officer at Teva. “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.”

Austedo XR is supplied as 6mg, 12mg, and 24mg strength extended-release tablets. The dose is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. The product is expected to be available later this year.

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