Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDOXR (deutetrabenazine) extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). AUSTEDO XR is an additional formulation of the currently marketed twice-daily AUSTEDO.
“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.”
Once-daily AUSTEDO XR has been shown to be therapeutically equivalent to the twice-daily formulation, providing another effective treatment choice. It will be available in three extended-release tablet strengths – 6 mg, 12 mg, and 24 mg – and can be taken with or without food. The new tablet strengths provide an updated regimen which may result in a decreased pill count for patients compared to the twice-daily formulation.
“Today’s approval marks an exciting milestone for patients with TD and HD chorea,” said Sven Dethlefs, PhD, Executive Vice President, North America Commercial at Teva. “Our commitment to patients suffering with these diseases is unwavering and we will continue our mission to address the needs of patients with neurodegenerative disorders.”
Since 2017, Teva has been supporting patients with TD and HD chorea and their prescribers by providing an effective treatment. AUSTEDO is the only vesicular monoamine transporter 2 (VMAT2) inhibitor with 3-year data for both the TD and HD chorea indications. TD is a highly debilitating movement disorder affecting one in four people who take certain mental health treatments. Chorea associated with HD is involuntary, random and sudden, twisting and/or writhing movements associated with this devastating disease.
AUSTEDO XR is expected to be available in the U.S. later this year.