FDA Approves Extended Release Austedo

The FDA has approved an extended-release version of Teva Pharmaceuticals’ Austedo (deutetrabenazine), a new once-daily formulation to treat adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).

Tardive dyskinesia is a chronic movement disorder that affects one in four people who take certain mental health treatments. It is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts. Huntington’s disease is a fatal neurodegenerative disease. Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington’s disease and occurs in about 90% of patients.

“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,” Eric Hughes, M.D., Ph.D., executive vice president of R&D and chief medical officer at Teva, said in a press release.

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 tablet strengths – 6 mg, 12 mg, and 24 mg. The extended-release version will be available later this year.

Teva officials didn’t respond requests for a list price of Austedo XR. The twice-daily Austedo has an average retail price of $6,039 for 60 tablets, according to GoodRx.

In October 2022, Teva published data from a three-year, open-label study of long-term treatment with the twice-daily Austedo in 119 patients with chorea. Exposure-adjusted incidence rates (EAIRs) were used to compare the frequency of adverse events (AEs) in this long-term open-label extension study. The study included 82 patients who completed the placebo-controlled First-HD trial, and 37 patients who converted from a stable tetrabenazine dose to Austedo.

Exposure-adjusted incidence rates were used to compare the frequency of adverse events (AEs) in this extension study with those in the short-term First-HD study. Common adverse events in the rollover and switch cohorts included: fall, depression, anxiety, insomnia, somnolence, and akathisia. There were no new safety concerns.