New once-daily option for the treatment of adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD) is available in 6 mg, 12 mg, and 24 mg tablet strengths and can be taken with or without food
- Once-daily AUSTEDO XR has been shown to be therapeutically equivalent to twice-daily AUSTEDO, providing another effective treatment choice for TD and HD chorea patients1
- In the longest TD clinical trial to date, twice-daily AUSTEDO demonstrated rapid TD symptom control as early as 2 weeks with sustained results observed through 3 years.1-5 Once-daily AUSTEDO XR contains the same active ingredient as twice-daily AUSTEDO
- Teva Shared Solutions® helps patients get started on AUSTEDO XR by navigating insurance, identifying financial assistance options and providing ongoing nurse adherence support
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA),today announced that once-daily AUSTEDOXR (deutetrabenazine) extended-release tablets are now available for adults in the United States in 6 mg, 12 mg and 24 mg tablet strengths. AUSTEDO XR was recently approved by the U.S. Food and Drug Administration (FDA) for adults living with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). AUSTEDO is the only vesicular monoamine transporter 2 (VMAT2) inhibitor with 3-year data that is indicated in adults for both TD and HD chorea indications.5,6
“We’re pleased to now make available a once-daily formulation for the many TD and HD chorea patients and caregivers who have requested that Teva provide this option,” said Sven Dethlefs, PhD, Executive Vice President, North America Commercial at Teva. “The twice-daily formulation will also remain available so that patients may have a choice for what works best for them. Teva will continue to work closely with the community to ensure patients and their healthcare providers are able to easily access this important medication.”
Since 2017, Teva has been supporting patients and their families with TD and HD chorea and their prescribers by providing an effective treatment option for their uncontrollable movements. Once-daily AUSTEDO XR has been shown to be therapeutically equivalent to the twice-daily formulation – offering a new and effective treatment choice.1 AUSTEDO XR may also result in a decreased pill count for patients compared to the twice-daily AUSTEDO. AUSTEDO XR and AUSTEDO are the only VMAT2 inhibitor TD treatments with no restrictions for use alongside CYP3A4/5 inducers.7,8
The Wholesale Acquisition Cost (WAC or “list price”) for AUSTEDO XR ranges from $2,360.25 – $7,080.70 for a 30-day supply depending on dosage strength. Actual costs for individual patients are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Approximately 90% of patients with insurance coverage are expected to pay $10 or less with financial assistance offerings.1 Teva is committed to helping patients who have been prescribed AUSTEDO XR access their medication. Teva continues to support with access, reimbursement, prescription pull-through and patient assistance. Savings on out-of-pocket costs may vary depending on the patient’s insurance provider and eligibility for participation in the co-pay assistance program. For more information regarding cost and coverage options for AUSTEDO XR through Teva Shared Solutions, visit MySharedSolutions.com.
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.9-11
About Chorea Associated with Huntington’s Disease (HD)
Huntington’s Disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems.12 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 approximately 90% of patients.12,13 Chorea can have a significant impact on daily activities and progressively limit peoples’ lives.12
About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets
AUSTEDO is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO.
INDICATIONS AND USAGE
AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.
