A new DRUG TRIALS SNAPSHOT is now available.
AUSTEDO is a drug used for the treatment of chorea in patients with Huntington’s disease.
Chorea is a condition characterized by uncontrolled, involuntary movements and is one of many symptoms that occur in patients with Huntington’s disease.
See more Drug Trial Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
AUSTEDO (deutetrabenazine)
(aw-STED-oh)
Teva Pharmaceuticals
Approval date: April 3, 2017
(aw-STED-oh)
Teva Pharmaceuticals
Approval date: April 3, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
AUSTEDO is a drug used for the treatment of chorea in patients with Huntington’s disease.
Chorea is a condition characterized by uncontrolled, involuntary movements and is one of many symptoms that occur in patients with Huntington’s disease.
How is this drug used?
AUSTEDO is a tablet that is taken with food once or twice a day depending on the daily dose.
What are the benefits of this drug?
AUSTEDO reduced chorea in Huntington’s disease patients.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
Subgroup analyses were conducted for sex and age. Analysis for different racial groups was not done because majority of patients were White.
- Sex: AUSTEDO worked similarly in men and women.
- Age: AUSTEDO worked similarly in patients below and above 65 years of age.
What are the possible side effects?
AUSTEDO may increase the risk of depression and suicide. Other serious side effects that AUSTEDO may cause include life threatening condition called neuroleptic malignant syndrome, restlessness (akathisia) and excessive sleepiness.
The most common side effects of AUSTEDO are sleepiness, diarrhea, dry mouth and tiredness.
Were there any differences in side effects among sex, race and age?
Overall the number of patients in the trial was small, and the number of patients who experienced side effects in each subgroup was limited; therefore differences in side effect among sex, race and age subgroups could not be determined.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved AUSTEDO based primarily on evidence from one clinical trial that enrolled 90 patients with chorea associated with Huntington’s disease. The trial was conducted in 34 centers in the United States and Canada.
The figure below summarizes how many men and women were in the clinical trial.
Figure 1. Baseline Demographics by Sex
Adapted from FDA Statistical review
The figure and table below summarize the percentage of patients by race in the clinical trial.
Figure 2. Baseline Demographics by Race
Adapted from FDA Statistical review
Table 1. Demographics by Race
Race | Number of patients | Percentage of patients |
|---|---|---|
White | 83 | 92 |
Black or African American | 5 | 6 |
Multiple | 2 | 2 |
Adapted from FDA Statistical review
Figure 3. Baseline Demographics by Age
Adapted from FDA Statistical review
How were the trials designed?
There was one trial that evaluated the benefit and side effects of AUSTEDO. In the trial, patients with chorea associated with Huntington’s disease were randomly assigned to receive either AUSTEDO or placebo for 12 weeks. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed.
The trials measured overall change in chorea using Total Maximal Chorea Score. On this scale, chorea is rated from 0 to 4 (with 0 representing no chorea) for 7 different parts of the body. The total score ranges from 0 to 28.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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