Clinical Study Details & Results of AUSTEDO® for HD Chorea Treatment

for

HD Chorea in Adults

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First goal of the study^1,2

To measure the effectiveness of AUSTEDO on:

HD chorea symptoms using the Total Maximal Chorea (TMC) score.
TMC score progress before, during, and at the end of the 12-week study.

Second goal of the study^1,2

To evaluate the effects of AUSTEDO on:

Overall HD symptoms, as reported by people and their doctors.
Limitations on people's ability to perform daily activities.

About the study¹:

90 people with HD chorea were studied for 12 weeks.

45 people were selected to take AUSTEDO (deutetrabenazine) and 45 people were selected to take placebo (inactive tablets).

Involuntary movements were measured at the beginning and end of the study, with movements also being observed at intervals throughout the 12-week period.

Gender²:

Female

44.4%

55.6%

Male

44.4% of participants in the study were female and 55.6% were male.

Medications people taking austedo were able to continue throughout the trial:

Antidepressants

62.2%

Antiepileptics

35.5%

Anti-Anxiety
Medications

15.5%

Chart showing antidepressants at 62.2%, antiepileptics at 35.5%, and anti-anxiety medications at 15.5%.

Understanding the TMC score

The TMC score is used to determine the effectiveness of HD chorea treatment. Seven parts of the body—including the face, mouth, arms, and legs—are scored from 0 to 4, with 0 indicating no chorea. A complete TMC score ranges from 0 to 28. The lower the score, the less chorea, or involuntary movements, exhibited by the person.^1,2

Areas of the body used to measure the effectiveness of AUSTEDO® on HD chorea with the TMC score.

More details about the study

Age range²:

23 – 74

Years old

Mean CAG Repeat Length²:

36

MIN

59

MAX

TMC Score at the Beginning of the study²:

8.0

MIN

21.5

MAX

Switching from tetrabenazine^1,2

If your doctor recommends switching to AUSTEDO from tetrabenazine, you can start AUSTEDO the day after you stop tetrabenazine. This means you can continue treating your HD chorea without missing a dose.
In a clinical study, 37 people with HD chorea switched overnight from tetrabenazine to AUSTEDO. People in the study received AUSTEDO at approximately half the dose of tetrabenazine.

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Approved Uses

AUSTEDO is a prescription medicine that is used to treat:

the involuntary movements (chorea) of Huntington’s disease. AUSTEDO does not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.
movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

It is not known if AUSTEDO is safe and effective in children.

IMPORTANT SAFETY INFORMATION

AUSTEDO can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions.
Do not start taking AUSTEDO if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is especially important when AUSTEDO is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of suicide.

Do not take AUSTEDO if you:

have Huntington’s disease and are depressed or have thoughts of suicide.
have liver problems.
are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking AUSTEDO. Do not start AUSTEDO if you stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure.
are taking reserpine. Do not take medicines that contain reserpine (such as Serpalan^® and Renese^®-R) with AUSTEDO. If your healthcare provider plans to switch you from taking reserpine to AUSTEDO, you must wait at least 20 days after your last dose of reserpine before you start taking AUSTEDO.
are taking tetrabenazine (Xenazine^®). If your healthcare provider plans to switch you from tetrabenazine (Xenazine^®) to AUSTEDO, take your first dose of AUSTEDO on the day after your last dose of tetrabenazine (Xenazine^®).
are taking valbenazine (Ingrezza^®).

Other possible serious side effects include:

Irregular heartbeat (QT prolongation). AUSTEDO increases your chance of having certain changes in the electrical activity in your heart. These changes can lead to a dangerous abnormal heartbeat. Taking AUSTEDO with certain medicines may increase this chance.
Neuroleptic Malignant Syndrome. Call your healthcare provider right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating.
Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia.
Parkinsonism. Symptoms include: slight shaking, body stiffness, trouble moving, trouble keeping your balance, or falls.

Sleepiness (sedation) is a common side effect of AUSTEDO. While taking AUSTEDO, do not drive a car or operate dangerous machinery until you know how AUSTEDO affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking AUSTEDO may increase any sleepiness caused by AUSTEDO.

The most common side effects of AUSTEDO in people with Huntington’s disease include sleepiness (sedation), diarrhea, tiredness, and dry mouth.

The most common side effects of AUSTEDO in people with tardive dyskinesia include inflammation of the nose and throat (nasopharyngitis) and problems sleeping (insomnia).

These are not all the possible side effects of AUSTEDO. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying
Medication Guide.

The brands listed are registered trademarks of their respective owners.

References: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information Parsippany, NJ. Teva Neuroscience, Inc. 2. Frank S, Testa CM, Stamler D, et al; Huntington Study Group ARC-HD Investigators. Long-term efficacy and safety of deutetrabenazine for chorea in Huntington's disease: results from the ARC-HD open-label study. Poster presented at: the 27th Annual Meeting of the Huntington Study Group (HSG); October 29-31, 2020. 3. Burgess JC, Davis B, Fogarty E, et al. Caregiver Guide for Mid to Late Stage Huntington's Disease: For Long-Term Care Facilities and In-Home Care Agencies. Huntington's Disease Society of America; 2014. Accessed January 28, 2022. http://hdsa.org/wp-content/uploads/2015/04/CaregiverGuide_Mid_Late_StageHD.pdf 4. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.