Efficacy demonstrated
across indications

Select a condition:

FIRST-HD

FIRST-HD: Significant and meaningful chorea control in Huntington’s disease with a demonstrated safety and tolerability profile1

AUSTEDO® tablets significantly improved Total Maximal Chorea (TMC) score by 2.5 points over placebo (4.4 vs 1.9) (P <0.0001)1

  • 21% improvement in TMC score with AUSTEDO® vs placebo (37% vs 16%, secondary endpoint)2
  • 33% of patients taking AUSTEDO® had a ≥6-point improvement in TMC score vs 2% with placebo3

FIRST-HD: TMC Score From Baseline to Maintenance Therapy (N=90, ITT)1,3

FIRST-HD: TMC Score From Baseline to Maintenance Therapy (N=90, ITT). Placebo vs AUSTEDO® (deutetrabenazine) tablets. 1.9 Point reduction vs baseline, 2.5 improvement vs placebo, 4.4 Point reduction vs baseline.

FIRST-HD was a randomized, 12-week, placebo-controlled study in patients with chorea associated with Huntington’s disease (HD). Patients were randomized to receive AUSTEDO® (n=45) or placebo (n=45). The mean dose of AUSTEDO® taken by patients at the end of the titration period was 40 mg/day. The primary efficacy endpoint was the treatment effect of AUSTEDO® vs placebo, as measured by the TMC score, an item of the Unified Huntington’s Disease Rating Scale (UHDRS), from baseline to maintenance. 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. The combined group mean TMC score at baseline was 12.7.1,2

The maintenance endpoint is the mean of the TMC scores for the Week 9 and Week 12 visits1

FIRST-HD: Baseline Demographics2,3

Characteristic AUSTEDO® (n=45) Placebo (n=45)
Mean age 55.4 years 52.1 years
Mean weight 163.4 lbs 163.4 lbs
Mean (SD) TMC score 12.1 (2.7) 13.2 (3.5)
Mean (SD) TMS 34.1 (13.2) 38.8 (15.2)
Antidepressant use 62% 53%

Discontinuation due to adverse events occurred in 2% of patients in both the AUSTEDO® and placebo groups1,2

In HD chorea, treatment success recognized by both physicians and patients

HD symptoms were rated as “much improved” or “very much improved” by both physicians and patients with AUSTEDO® vs placebo1,2

FIRST-HD: Global Impression of Change at the End of Treatment for AUSTEDO® Compared to Placebo (N=90, ITT)1-3

Overall HD symptoms rated as "much improved" or "very much improved" at Week 12 (secondary endpoint), 42% of Physicians Observed Treatment Success (P=00.002), 51% of Patients Observed Treatment Success (P=0.002)

FIRST-HD was a randomized, 12-week, placebo-controlled study in patients with chorea associated with HD. Patients were randomized to receive AUSTEDO® (n=45) or placebo (n=45). The mean dose of AUSTEDO® taken by patients at the end of the titration period was 40 mg/day. The primary efficacy endpoint was the treatment effect of AUSTEDO® vs placebo, as measured by the TMC score, an item of the UHDRS, from baseline to maintenance. 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. The combined group mean TMC score at baseline was 12.7.1,2


  • The Patient Global Impression of Change (PGIC) and the Clinical Global Impression of Change (CGIC) are single-item questionnaires that ask patients and physicians to assess overall HD symptoms3
  • Responses can range from “very much worse” (-3) to “very much improved” (+3) on a 7-point scale3
  • Treatment success was defined as a rating of “much improved” or “very much improved” at Week 123

Would you like information on AUSTEDO® for treatment of TD in adults and chorea associated with HD?

Register now

You are about to leave this site

You are about to leave AUSTEDO.com and enter a website operated by a third party. Teva is not responsible for and does not control the content contained on this third-party website linked to AUSTEDO.com.

Are you a healthcare professional?

The information on this site is intended for healthcare professionals in the United States. Are you a healthcare professional in the United States?

Indications and Usage

AUSTEDO® is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.

Important Safety Information

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO® is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO® is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO® is also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®).

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO® may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO® in their patients by assessing the effect on chorea and possible adverse effects.

QTc Prolongation: Tetrabenazine, a closely related VMAT2 inhibitor, causes an increase in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO® who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor. Dose reduction may be necessary. The use of AUSTEDO® in combination with other drugs known to prolong QTc may result in clinically significant QT prolongations. For patients requiring AUSTEDO® doses greater than 24 mg per day who are using AUSTEDO® with other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of AUSTEDO® or the other drugs. AUSTEDO® should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO®; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO® may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO® dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO® may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO® dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO®. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO® and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO®.

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

CYP2D6 Metabolism: In patients who are poor CYP2D6 metabolizers or are taking strong CYP2D6 inhibitors, the total daily dosage of AUSTEDO® should not exceed 36 mg (maximum single dose of 18 mg).

Common Adverse Reactions: The most common adverse reactions for AUSTEDO® (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO® (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.

Please see accompanying full Prescribing Information, including Boxed Warning.

References: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Teva Pharmaceuticals USA, Inc. 2. Huntington Study Group, Frank S, Testa CM, et al. Effect of deutetrabenazine on chorea among patients with Huntington disease: a randomized clinical trial. JAMA. 2016;316(1):40-50. 3. Data on file. Teva Neuroscience, Inc.