FDA approves more Austedo XR one-pill-a-day tablets
Extended-release tablets approved in US to treat Huntington's chorea
The U.S. Food and Drug Administration (FDA) has authorized new dosage strengths of Austedo XR (deutetrabenazine) extended-release tablets for managing chorea, or involuntary movements, in adults with Huntington’s disease.
Teva Pharmaceuticals’ Austedo XR is an extended-release formulation of Austedo (also by Teva) that is meant to be taken once a day, instead of the twice-daily regimen needed with its predecessor.
The extended-release version, which comes in tablets, had previously been available in three dose strengths: 6, 12, and 24 mg. Now, there are an additional four dose strengths of Austedo XR available: 30, 36, 42, and 48 mg, according to a Teva press release.
Austedo XR’s recommended starting dose is 12 mg once daily, which can be gradually increased by 6 mg per week up to a maximum of 48 mg daily. So, the newly available dose-strength tablets mean that everyone taking Austedo XR at clinically therapeutic doses (24-48 mg/day) will only have to take one pill per day.
“This latest Austedo XR approval provides patients with the same proven efficacy, but now with the convenience of a one pill, once-daily option for clinically therapeutic doses as established by the pivotal clinical trials to help control involuntary movements that can make carrying out basic daily activities difficult,” said Rakesh Jain, MD, a clinical professor of psychiatry at Texas Tech University School of Medicine.
4 new strengths of Austedo XR aim to give patients ‘dosing flexibility’
In addition to Huntington’s chorea, Austedo XR is approved in the U.S. to treat another movement disorder called tardive dyskinesia, or TD.
“Knowing patients living with TD and HD [Huntington’s disease] chorea are also managing other underlying concomitant conditions, it is important that treatment options for these chronic movement disorders are not only effective, but keep the patient experience in mind,” Jain said.
Austedo was approved by the FDA in 2017 based on data from the Phase 3 First-HD clinical trial (NCT01795859), which demonstrated the therapy outperformed a placebo at easing chorea in people with Huntington’s.
Patients given Austedo reported reductions in chorea as soon as two weeks after starting treatment; long-term data have since shown consistent effects of the therapy out to three years of use.
Austedo XR was cleared in the U.S. last year based on pharmacological data showing it delivered equivalent amounts of the medication as the original twice-daily version.
Austedo … has continued to evolve — having received approval for Austedo XR, our once-daily extended-release formulation in February 2023. This latest milestone offers a streamlined treatment regimen for clinically therapeutic doses with the broadest dosing flexibility.
“Since our launch of Austedo in 2017, we have been committed to helping people living with TD and HD chorea treat these chronic, involuntary movements,” said Dell Faulkingham, senior vice president and head of U.S. innovative medicines at Teva.
“Austedo, backed by the longest efficacy and tolerability data to date, has continued to evolve — having received approval for Austedo XR, our once-daily extended-release formulation in February 2023. This latest milestone offers a streamlined treatment regimen for clinically therapeutic doses with the broadest dosing flexibility,” Faulkingham said.
According to Teva, about 90% of patients with insurance coverage can expect to pay $10 or less for each prescription of Austedo XR with financial assistance offerings. Through its Shared Solutions service, the company provides support with access and reimbursement of Austedo XR and Austedo, in addition to patient assistance.
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