Austedo XR, a Once-Daily Formulation of Deutetrabenazine, Now Available

Austedo^® XR (deutetrabenazine) extended-release tablets are now available for the treatment of adults with tardive dyskinesia and chorea associated with Huntington disease.

Austedo XR is a vesicular monoamine transporter 2 inhibitor. The product received approval from the Food and Drug Administration (FDA) in February 2023 based on dose proportionality and bioequivalence studies comparing Austedo XR (once daily) tablets to Austedo (twice daily) tablets. 

The once-daily formulation was found 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.

Austedo XR is supplied in 6mg, 12mg, and 24mg strength extended-release tablets in 30-count bottles. The dose is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. 

“We’re pleased to now make available a once-daily formulation for the many [tardive dyskinesia] and [Huntington disease] chorea patients and caregivers who have requested that Teva provide this option,” said Sven Dethlefs, PhD, Executive Vice President, North America Commercial at Teva. “The twice-daily formulation will also remain available so that patients may have a choice for what works best for them. Teva will continue to work closely with the community to ensure patients and their health care providers are able to easily access this important medication.”

The Company is offering the Teva Shared Solutions program to assist eligible patients.