Huntington’s patients in US have new option of Austedo XR
Chorea treatment taken just once daily now available to patients
Austedo XR, an extended-release oral formulation of Austedo (deutetrabenazine), is now commercially available in the U.S. as a treatment for adults with chorea, or uncontrolled muscle contractions, associated with Huntington’s disease.
The new formulation is available in tablet strengths of 6 mg, 12 mg, and 24 mg, and is taken once a day, with or without food. This contrasts with the twice-a-day dosing regimen of the original formulation of Austedo, which is still available. With that formulation, the available dosing strengths are 6 mg, 9 mg, and 12 mg dosing, but the tablets must be taken with food.
The market availability of Austedo XR comes nearly three months after the therapy was approved by the U.S. Food and Drug Administration (FDA) for this indication. The treatment, developed by Teva Pharmaceuticals, also was approved for adults with tardive dyskinesia, another movement disorder marked by chorea.
“We’re pleased to now make available a once-daily formulation for the many [tardive dyskinesia] and [Huntington’s disease] chorea patients and caregivers who have requested that Teva provide this option,” Sven Dethlefs, PhD, executive vice president of North America Commercial at Teva, said in a company press release.
“The twice-daily formulation will also remain available so that patients may have a choice for what works best for them,” Dethlefs said.
Once-daily Austedo formulation now available as chorea treatment
Chorea, characterized by involuntary, often abrupt movements, is a common symptom of Huntington’s, a hereditary disorder caused by the excessive release of the signaling molecule dopamine by nerve cells.
The active ingredient in Austedo specifically targets a protein called VMAT2 that is needed to release dopamine. As such, it is expected to reduce the amount of dopamine released by nerve cells, thereby helping to ease these abnormal movements.
The original formulation of the therapy, which is taken twice per day, was approved by the FDA in 2017. The new extended-release formulation contains the same active agent, but was designed to allow once-daily dosing.
The FDA’s approval of Austedo XR was supported by clinical trial data showing the new formulation is therapeutically equivalent to the original version, meaning it provides the same amount of the active medication.
Data presented at last month’s American Academy of Neurology annual meeting showed that Austedo XR delivers an equal amount of the active medication as the original formulation. It also has comparable pharmacokinetics, meaning therapy’s movement into, through, and out of the body, to Austedo.
Like the original formulation, Austedo XR is started at a low dose, and then the dose is gradually increased to optimize symptom control while minimizing side effects, which may include sleepiness, dry mouth, fatigue, and diarrhea.
Depending on the dosage used, the list price for a 30-day supply of Austedo XR ranges from $2,360.25 to $7,080.70, according to Teva. Most patients do not end up actually paying the list price, as those prices don’t include rebates and other discounts that can apply.
According to Teva, when accounting for financial assistance offerings, about 90% of patients with insurance coverage are expected to pay $10 or less for a 30-day supply of Austedo XR. The company offers a program called Teva Shared Solutions to help patients access the medication.
“Teva will continue to work closely with the community to ensure patients and their healthcare providers are able to easily access this important medication,” Dethlefs said.