FDA approves once-daily formulation of Austedo for Huntington’s chorea

The new version is expected to be launched commercially later this year

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Austedo XR, a new extended-release formulation of Austedo (deutetrabenazine) has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chorea — involuntary muscle contractions — associated with Huntington’s disease.

Austedo XR contains the same active agent as the original therapy, but is taken just once a day, with or without food, instead of twice daily. The approval also covers adults with tardive dyskinesia, a movement disorder.

The new version is expected to be commercially launched later this year, according to its developer Teva Pharmaceuticals. Austedo XR will be available in three dosing strengths — 6, 12, and 24 mg.

“Today’s approval marks an exciting milestone for patients with TD [tardive dyskinesia] and HD [Huntington’s disease] chorea,” said Sven Dethlefs, PhD, executive vice president of North America commercial at Teva, in a company press release. “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.”

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A common symptom of Huntington’s, chorea is caused by nerve cells releasing excessive amounts of a chemical messenger called dopamine, which triggers muscle cells to contract.

Within nerve cells, dopamine is packaged into tiny vesicles that are shipped to the end of the nerve fiber to release the chemical messenger to the muscle cells they control.

Austedo blocks the activity of vesicular monoamine transporter 2 (VMAT2), a protein needed to move these vesicles. By blocking VMAT2, the therapy reduces excessive dopamine signaling from nerve cells, reducing abnormal muscle contractions.

The twice-daily formulation was approved by the FDA in 2017 to treat adults with Huntington’s-associated chorea or tardive dyskinesia.

The approval in Huntington’s was supported by data from a Phase 3 clinical trial, called First-HD (NCT01795859), that tested the therapy against a placebo in 90 people with Huntington’s-related chorea. Results showed Austedo outperformed a placebo at easing the severity of chorea after three months.

The FDA’s approval of Austedo XR was based on data showing the once-a-day extended-release formulation was therapeutically equivalent to the original version, according to Teva.

The company also believes the once-daily formulation may let patients take fewer pills overall, making it easier to ensure they’re taking all their medicine as needed.

“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, Teva’s executive vice president of R&D and chief medical officer. “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’s ability to improve speech, walking, and balance in adults with Huntington’s is being evaluated in a Phase 2/3 trial (NCT04713982) sponsored by the Vanderbilt University Medical Center and conducted in collaboration with Teva. The study may still be recruiting at Vanderbilt.