Data

Clinical & Real-World Studies

Significant and meaningful reduction of TD severity at Week 121-3

ARM-TD: Change in AIMS Total Score From Baseline to Week 12 (N=113; P=0.019)2

ARM-TD: ~2x reduction in AIMS score with AUSTEDO® (deutetrabenazine) tablets vs placebo at ~38 mg/day from Baseline to Week 12 (N=113).

~2X REDUCTION

in TD severity at Week 12 vs placebo

~38 mg/day2,4*


Study used response-driven dosing approach: Patients titrated to effective and tolerable symptom control.1,2

Majority of patients achieved significant AIMS score reduction

  • ~70% of patients saw a ≥10% AIMS score reduction at Week 12 with AUSTEDO4†

Movement improvement in 2 placebo-controlled pivotal studies1-3

  • Early response as soon as Week 2 (exploratory analysis)
  • Significant response at Week 12 vs placebo
  • -3.0 vs -1.6 in ARM-TD (~38 mg/day,* P=0.019)
  • -3.3 vs -1.4 in AIM-TD (36 mg/day, P=0.001)

    AIM-TD: Change in AIMS Total Score From Baseline to Week 12 (N=222)1,3

    AIM-TD: >2x reduction in TD severity with AUSTEDO 36 mg/day vs placebo from Baseline to Week 12 (N=222).

    >2X REDUCTION

    in TD severity with AUSTEDO
    36 mg/day vs placebo1,3

  • Psychiatric stability maintained4‡
Pivotal study designs
ARM-TD (N=113)1,2,4
Flexible-dose trial
  • 12-week, randomized, double-blind, placebo-controlled Phase 2/3 trial
  • Patients were randomized 1:1 to receive AUSTEDO or placebo
  • Patients in AUSTEDO arm started at 12 mg/day, and dose was increased in 6 mg/day weekly increments based on response and tolerability, up to 48 mg/day max dose
  • Average age = 55
  • Generally even distribution across genders in both arms
  • ~83% of patients were taking an antipsychotic drug at baseline

Primary Endpoint: Change in AIMS total score from baseline to Week 12

Mean baseline AIMS score:

  • Placebo: 9.6
  • AUSTEDO: 9.7

Patients who completed ARM-TD or AIM-TD were eligible to roll over into the long-term open-label extension study (RIM-TD).5

AIM-TD (N=222)1,3,4
Fixed-dose trial
  • 12-week, randomized, double-blind, placebo-controlled Phase 3 trial
  • Patients were randomized 1:1:1:1 to receive 1 of 3 fixed doses of AUSTEDO (12 mg, 24 mg, or 36 mg), or placebo
  • Patients in AUSTEDO arms started at 12 mg/day. Dose was increased in 6 mg/day weekly increments until fixed “target” dose of 12 mg, 24 mg, or 36 mg/day was reached
  • Average age = 57
  • Patients were 52% female, 48% male
  • 78% of patients were taking an antipsychotic drug at baseline

Primary Endpoint: Change in AIMS total score from baseline to Week 12 in 36 mg/day arm vs placebo

Mean baseline AIMS score:

  • Placebo: 9.5
  • AUSTEDO 12 mg/day: 9.6
  • AUSTEDO 24 mg/day: 9.4
  • AUSTEDO 36 mg/day: 10.1

Patients who completed ARM-TD or AIM-TD were eligible to roll over into the long-term open-label extension study (RIM-TD).5

Patients who completed ARM-TD or AIM-TD were eligible to roll over
into the long-term open-label extension study (RIM-TD).5

Patients in the ARM-TD and AIM-TD studies received the AUSTEDO BID formulation.1,5



AIMS, Abnormal Involuntary Movement Scale; LS, least squares; TD, tardive dyskinesia.

*Mean total dose.2

†Versus ~42% with placebo, P=0.0032.4

‡Evaluations performed using: 1. The Hospital Anxiety and Depression Scale (HADS), a self-report questionnaire that offers an efficient way to screen patients for psychological comorbidities, showed no worsening at Week 12 in AIM-TD and ARM-TD; 2. The Columbia-Suicide Severity Rating Scale (C-SSRS), a measure used to identify and assess individuals at risk for suicide, was assessed at any visit during the 12-week randomized trials (AIM-TD and ARM-TD).3,4,6

3X LONGER
than any other TD extension study4,5,7

Rapid response as early as Week 22,3§

Increasing improvement
observed over 3 years in an
OLE study5||

AIMS Score Reduction in Pivotal and OLE Studies2,4,5

RIM-TD: Mean change in AIMS score over the long-term period. 3.0-point reduction vs baseline at 12 weeks with an average dose of ~38 mg/day for patients in ARM-TD. 6.6-point reduction vs baseline at 3 years for patients with an average dose of ~39 mg/day in RIM-TD.

Patients in the pivotal and RIM-TD studies received the AUSTEDO BID
formulation.1,5

3% of patients did not complete the study due to lack of efficacy.5

11-point mean reduction at Week 145

for patients with >14-point baseline AIMS score in a post hoc analysis of RIM-TD (n=40)8

  • Percentage reduction from baseline was comparable for patients with ≤14-point baseline AIMS score (~56%) and >14-point baseline AIMS score (~60%)

At 3 years4,5,9-11:

  • Tolerability comparable to pivotal trials, with no new safety signals
  • 90% mean compliance rate**
  • 50% or more reduction in AIMS score for the majority of patients
    ≥50% improvement in AIMS score through Week 145. At Week 145, 67% of patients saw ≥50% improvement, and 42% of patients saw ≥70% improvement.
  • Consistent results across subgroups:

The largest elderly population of any TD clinical study (n=78)

Sustained results across 3 years for elderly patients (aged ≥65 years) and younger patients (aged 21-64 years)††

Elderly and Younger Subgroups: AIMS Score Reduction in RIM-TD

Elderly patients (≥65 years old) saw -6.2 reduction at 3 years at >36 mg/day mean dose.

Similar dose and response at Week 145 (>36 mg/day)‡‡

Similar safety and tolerability profile

Similar percentage of patients remained in the study at Week 145

Patients in the RIM-TD study received the AUSTEDO BID formulation.1,5

See a long-term care resident’s journey with TD movement improvement

Click to play video. play button Mobile Play Icon

Onscreen text:


TREATING TD IN LTC


NORMA’S SYMPTOM IMPROVEMENT STORY


Age:79


Primary conditions: Mood disorder, anxiety disorder, obsessive-compulsive disorder, and primary insomnia, along with pulmonary, cardiovascular, and gastrointestinal issues


Disclaimer on bottom of screen:


This was an individual patient’s experience. Results may vary. Participants were compensated by Teva Neuroscience, Inc.


LTC, long-term care; TD, tardive dyskinesia.


Onscreen text:


Norma is an LTC resident with TD. Before treatment, she had a moderate Abnormal Involuntary Movement Scale (AIMS) score of 7.


Her involuntary movements were significantly impacting her physical, psychological, and social health.


Dr. Patel:


I was given consultation on Norma initially for treatment of her psychiatric condition. And the first time I saw her is when I noticed she had symptoms of tardive dyskinesia.


Her ability to swallow was affected. She had trouble with a lot of drooling because of her tardive dyskinesia and tongue movements and jaw movements. So she constantly had to carry a washcloth and wipe her mouth all the time, and she was embarrassed by it. She was always scared that she would choke.


Onscreen text:


DR. AMITA PATEL, MD


GERIATRIC PSYCHIATRIST IN LTC


Dr. Patel:


Norma’s tardive dyskinesia movements were severe enough that it really destabilized her underlying mental health condition, and I had to adjust her psychoactive medications for it.


Onscreen text:


KIM MIDDLETON


DIRECTOR OF NURSING IN LTC


Kim:


I think the movements affected Norma physically. Functionally, she needed more help with her ADLs or her activities of daily living, such as getting dressed, toileting, even just brushing her teeth—just the everyday functions of her life.


Onscreen text:


JENNIFER


NORMA’S DAUGHTER


Jennifer:


I talk to my mom a lot, and when I can't understand her, you know, that's hard for me. It's definitely hard for her because I have to have her repeat things all the time.”


The physical activities changed. She kind of had to stop, you know, crocheting and certain things like that.


Onscreen text:


Any resident who has taken or is currently taking an antipsychotic is at risk for developing TD.


Fortunately, Norma’s care team recognized her TD symptoms and the negative impact they were having on her life.


Dr. Patel:


The symptoms that we saw in Norma are not only typical for Norma, we see that quite often in other residents that I treat with tardive dyskinesia in long-term care facility. Just because residents are in long-term care facility, doesn't mean they don't deserve maximum quality of life.


Treating TD was really important for Norma because TD was not only affecting her socially, physically, and psychologically, but it was worsening her depression and anxiety.


It was very important for me to pick the correct medication, where there is no drug interaction with the current regimen she's on because she was quite stable on her current mental health medication, and I didn't want to adjust any of her current psychoactive medication, if possible.


Onscreen Indication and Black Box Warning:


AUSTEDO XR® and AUSTEDO® are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington's disease.


IMPORTANT SAFETY INFORMATION


Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and 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 XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.


Please see additional Important Safety Information at the end of this video.


Dr. Patel:


I have had a lot of experience using AUSTEDO XR in other patients. I've had great results with this medication, especially in Norma’s case.


It was easy to add AUSTEDO XR to the current medications that Norma was taking. I could do a slow titration and watch for any side effects.


Onscreen text:


Once Norma began treatment, she saw a significant improvement in her movements—and so did those around her.


Onscreen text:


Before treatment AIMS score of 7


After treatment AIMS score of 3


Dr. Patel:


Norma is currently on 48 milligrams and her current AIMS score is 3. But if you really talk about the improvement she has had, it really has given her better quality of life. She is now able to speak better. We don't have to ask her to repeat herself all the time. She doesn't have to carry the washcloth to wipe her lips all the time. She is not afraid of choking. Her movements of her jaw and her fingers are so much better. She's not embarrassed. She's not afraid that people are going to make fun of her.


Kim:


I could tell that AUSTEDO XR was making a difference in Norma's life.


I noticed that she was being involved more in the social activities due to the involuntary movements decreasing. So, I feel like Norma's quality of life was improving.


I think her movement improvement has made it easier to care for her because she is more independent. She can do more of those, you know, daily things on her own.


Jennifer:


My feeling since she started taking AUSTEDO XR, is relief. I don't have to worry quite as much about her possibly hurting herself or even with eating or drinking and choking. And I feel I'm proud of her for her leaps and bounds.


It has been a very noticeable change. As time goes by, she can do a little bit more and a little bit more. And when she handed me that little blanket that she made, I was really shocked because the stitching was really great.


When I see Mom's progress, it just fills me with joy. It's a relief to know that she is getting the help, the care, and the medications that she needs.


Kim:


So it's important to identify TD symptoms and to help people we identify with those movements to get them treatment, to decrease the risk of them falling, or having to go to the emergency department, or losing weight.


I think the care team, I can probably speak for all of them. When you see someone like Norma improve their quality of life, I think I can say that it just brings a lot of joy to our hearts and our lives. And it just reaffirms why we come here every day and why we do what we do.


Onscreen text:


Learn more about AUSTEDO XR and how it can make a difference for your residents with TD.


Onscreen ISI scroll:


INDICATIONS AND USAGE


AUSTEDO XR and AUSTEDO are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington's disease.


IMPORTANT SAFETY INFORMATION


Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and 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 XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.


Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are 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 or valbenazine.


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


QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and 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 XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.


Akathisia, Agitation, and Restlessness: AUSTEDO XR and 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 XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.


Parkinsonism: AUSTEDO XR and 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 XR or 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 XR and 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 XR or 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 XR and 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.


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. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.


Please see full Prescribing Information, including Boxed Warning, at AUSTEDOhcp.com.

††In a post hoc subgroup analysis of RIM-TD.

‡‡Mean total dose.

In a post hoc subgroup analysis of RIM-TD (open-label extension, non-blinded)

Sustained results across 3 years in patients with mood disorders

Mood Disorder Subgroup§§: AIMS Score Reduction in the RIM-TD Study

AIMS score reduction in patients with mood disorders over the long term. 7.1-point reduction vs baseline.

Growing percentage of patients with mood disorders achieved ≥50% AIMS score improvement over time11

Patients With ≥50% Reduction in AIMS Total Score

AIMS score improvement in patients with mood disorders over the long term.

§§The mood disorder subgroup included patients with bipolar disorder and depression.

||||Mean total dose.11

In a post hoc subgroup analysis of RIM-TD (open-label extension, non-blinded)

Sustained results across 3 years in patients with schizophrenia

Schizophrenia Subgroup¶¶: AIMS Score Reduction in RIM-TD

AIMS score reduction in patients with schizophrenia over the long term. 6.3-point reduction vs baseline.

Growing percentage of patients with schizophrenia achieved ≥50% AIMS score improvement over time11

Patients With ≥50% Reduction in AIMS Total Score

AIMS score improvement in patients with schizophrenia over the long term.

Patients in the RIM-TD study received the AUSTEDO BID formulation.1,5

¶¶The schizophrenia subgroup included patients with schizophrenia and schizoaffective disorder.4

##Mean total dose.11

Download the reprint for more results from RIM-TD

RIM-TD study design

RIM-TD was a single-arm, open-label extension study of the use of AUSTEDO in patients from the 2 placebo-controlled trials, AIM-TD and ARM-TD. Patients who opted to roll over completed a 1-week washout and then started AUSTEDO at 12 mg/day, which was titrated by 6 mg/day weekly to identify a dose that adequately controlled TD and was tolerated by the patient. The safety and tolerability of AUSTEDO were assessed over 3 years.12

Study design schematic for the RIM-TD long-term study.

​

Table of baseline characteristics for the RIM-TD long-term study including patient demographics, comorbidities, and patient clinical characteristics.

DRA, dopamine-receptor antagonist.

FDA approved: One pill, once-daily for all AUSTEDO XR doses1

Sustained concentrations with a single daily pill1

  • Bioequivalence established between single-pill and multiple-pill doses of once-daily AUSTEDO XR based on pharmacokinetic studies4
  • Data support bioequivalence of single-pill and multiple-pill AUSTEDO XR across full dosing range1

Plasma Concentration Over 96 Hours: AUSTEDO XR 48 mg vs AUSTEDO XR 2×24 mg QD4***

Bioequivalence Data: Plasma Concentration over 96 hours in AUSTEDO XR 48 mg vs AUSTEDO XR 2x24 mg QD, data support bioequivalence of one pill, once-daily AUSTEDO XR and AUSTEDO XR across the full dosing range of AUSTEDO XR.

***Based on active alpha and beta metabolites.4

Bioequivalence has also been established between AUSTEDO XR and
AUSTEDO BID4
  • Bioequivalence of once-daily AUSTEDO XR has been established in pharmacokinetic profile studies4†††
  • Peak plasma concentrations (Cmax) of AUSTEDO XR are reached within approximately 3 hours1

Plasma Concentration at Steady State Over 24 Hours: AUSTEDO XR vs BID4‡‡‡

Bioequivalence Data: Plasma Concentration at Steady State Over 24 Hours in AUSTEDO XR vs BID, data support bioequivalence of XR and BID across the full dosing range of AUSTEDO.

†††Data support bioequivalence of XR and BID across the full dosing range of AUSTEDO.1

‡‡‡Based on active alpha and beta metabolites.4

OLE, open-label extension.

§Response observed as early as Week 2 in placebo-controlled studies.2,3

||71% of patients at Week 145 saw improvement relative to Week 15.4

Versus -1.6 with placebo (P=0.019).1,2

#Mean total dose.4

**Overall compliance based on pill counts.4

In a real-world survey of 209 patients with TD taking AUSTEDO XR, the majority of patients reported movement reduction (>90%)4

As a result of movement reduction with AUSTEDO XR, surveyed patients reported improvements in daily living4

Improved emotional
well-being
  • Improved overall emotional well-being (~79%)
  • Less embarrassment (~73%)
  • Improved self-esteem (~68%)
Improved social well-being
  • Increased comfort spending time with family and friends (~79%)
  • Increased comfort speaking to others (~76%)
  • Increased comfort leaving the house (~75%)
Improved physical
well-being & productivity
  • Improved overall physical health (~58%)
  • Improved work or school life, including working from home (~53%)
Nearly all patients said taking AUSTEDO XR is easy

High rate of overall satisfaction (~90%) with AUSTEDO XR reported across younger (19-64 years) and elderly (≥65 years) subgroups

~97% plan to continue
taking AUSTEDO XR
Hear more about AUSTEDO XR from real patients

Watch Charlene and Sherland’s treatment journeys with AUSTEDO

Improvement Over Time

See Charlene’s symptom improvements with AUSTEDO over 2+ years play-circle.svg play-circle-active.svg

Onscreen text/quote bubbles:

Improvement Over Time: An Update on Charlene 2+ Years Later

Age: 65

Primary condition: Schizoaffective disorder


Disclaimer at bottom of screen:

This was an individual patient’s experience on AUSTEDO BID. Results may vary.


Onscreen text/quote bubbles:

“After a little over two years on AUSTEDO…my feet aren’t moving all the time. My hands aren’t moving all the time.”


“I can do something else with my hands now. I can tie my shoes…I can do things that people consider normal, that weren’t normal for me.”


CHARLENE’S JOURNEY OVER 2+ YEARS


When Charlene developed TD, she was told her involuntary movements would last forever. But she wasn’t ready to give up…


After starting AUSTEDO, Charlene began to see an improvement in her involuntary movements.


“I used to move my fingers without realizing, and I rocked…and I’m not doing that hardly at all…it is better.” – Charlene


“So do you think we’re at the right dose…or do you think we still have room for improvement?” – HCP


“I think there’s room for improvement.” – Charlene


As her dose was increased, Charlene’s movements continued to improve.


“Your movements look better…your fingers look pretty stable…” – HCP


“Yeah, and my mouth isn’t going 20 miles per hour…” – Charlene


Charlene’s doctor increased her dose to 48 mg/day, where Charlene experienced effective and tolerable symptom improvement.


Now, more than 2 years after starting treatment, Charlene can’t imagine going back to life without AUSTEDO.


“After a little over two years on AUSTEDO…my feet aren’t moving all the time. My hands aren’t moving all the time.” – Charlene


“I can do something else with my hands now. I can tie my shoes…I can do things that people consider normal, that weren’t normal for me.” – Charlene


“I don’t want to go back to the motions, so I prefer to stay on AUSTEDO…it helps and I don’t want to lose that.” – Charlene


Disclaimer at bottom of screen:

No clinical trials have been conducted to suggest that AUSTEDO affects the outcomes listed above.


Onscreen text/quote bubbles:

What could long-term results mean for your patients like Charlene?


See the rest of Charlene’s story at AUSTEDOhcp.com


Disclaimer at bottom of screen:

Once-daily AUSTEDO XR Is available.


Bioequivalence of once-daily AUSTEDO XR has been established with AUSTEDO BID based on pharmacokinetic profile studies. When two formulations are shown to be bioequivalent, they are considered to be therapeutically equivalent.


Onscreen ISI scroll:

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.


IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease:

AUSTEDO XR and 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 XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

 

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are 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 or valbenazine.


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


QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and 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 XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.


Akathisia, Agitation, and Restlessness: AUSTEDO XR and 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 XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.


Parkinsonism: AUSTEDO XR and 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 XR or 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 XR and 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 XR or 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 XR and 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.


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. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets. Please see full Prescribing Information, including Boxed Warning, on AUSTEDOhcp.com.


Onscreen text:

This was an individual patient’s experience. Results may vary.


REFERENCES: AUSTEDO XR® (deutetrabenazine) extended-release tablets and AUSTEDO® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. Chow SC. Bioavailability and bioequivalence in drug development. Wiley Interdiscip Rev Comput Stat. 2014;6(4):304-312. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.

Sherland Shares Her Truth About TD

Learn how treatment with AUSTEDO over 4+ years got Sherland back to what she loved play-circle.svgplay-circle-active.svg

For more videos, visit the YouTube page.YouTube play icon

APPROVED USES


AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are prescription medicines that are used to treat:


the involuntary movements (chorea) of Huntington’s disease. AUSTEDO XR and AUSTEDO do 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 XR and AUSTEDO are safe and effective in children.


IMPORTANT SAFETY INFORMATION


AUSTEDO XR and AUSTEDO can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Do not start taking AUSTEDO XR or 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 XR or 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.


Individual results may vary.


Please see the Important Safety Information at the end of this video.


Once my involuntary movements were under control, I felt like I can live again. I can go outside again. I can be a part of the world again.


“Hello, my name is Sherland. I’m from Roxboro, North Carolina. I’m a published author. I edit novels. I am a great lover of literature and nature.”


Dear Sherland,


When this first started, you weren’t aware something was wrong… until your daughter asked why you were so fidgety. She told you that your mouth twitched when you talked and your fingers and feet constantly moved. When you realized you couldn’t control these movements, you grew self-conscious. TD transformed you from someone who loved conversing with strangers, to a timid individual who avoided family and friends because everyone asked when you had a stroke, not if you had a stroke, but when […]. TD left you feeling despondent and lonely.


My doctors told me that my involuntary movements…were side effects caused by my mental health medication. When I first found out that I had tardive dyskinesia, I did as much research as I could about it. It felt good to know that I had a name to put with what I was experiencing. And I felt like I wasn’t alone because other people were going through the same thing. The doctor told me when he recommended AUSTEDO, ‘I’ve heard of this treatment that I think might help you.’ AUSTEDO has allowed me to continue taking my mental health medication, because it’s really important. I suffer from major depression and bipolar. Before, I was just feeling hopeless. And after about two or three weeks I would say, I just started getting back out there because I had something to look forward to. I started seeing real progress with the involuntary movements. I have to say that it really made a difference in my life. I have confidence. I would tell them that there is a treatment, and it’s called AUSTEDO. And that you don’t have to feel hopeless like I did. You don’t have to struggle like I did. You can go to your doctor. You have a name, TD, to put with the symptoms. Ask about AUSTEDO and be proactive with your own health, because if you’re not, then who else will be? There’s no guarantees in life—but this is a good treatment plan for me.


APPROVED USE


AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are prescription medicines that are used to treat:


the involuntary movements (chorea) of Huntington’s disease. AUSTEDO XR and AUSTEDO do 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 XR and AUSTEDO are safe and effective in children.


IMPORTANT SAFETY INFORMATION


AUSTEDO XR and AUSTEDO can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Do not start taking AUSTEDO XR or 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 XR or 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 XR or AUSTEDO if you:


have Huntington’s disease and are depressed or have thoughts of suicide.


have liver problems.


are taking reserpine. Do not take medicines that contain reserpine with AUSTEDO XR or AUSTEDO. If your healthcare provider plans to switch you from taking reserpine to AUSTEDO XR or AUSTEDO, you must wait at least 20 days after your last dose of reserpine before you start taking AUSTEDO XR or AUSTEDO.


are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking AUSTEDO XR or AUSTEDO. Do not start AUSTEDO XR or 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 tetrabenazine. If your healthcare provider plans to switch you from tetrabenazine to AUSTEDO XR or AUSTEDO, take your first dose of AUSTEDO XR or AUSTEDO on the day after your last dose of tetrabenazine.


are taking valbenazine.


Other possible serious side effects include:


Irregular heartbeat (QT prolongation). AUSTEDO XR and 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 XR or 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 XR and AUSTEDO. While taking AUSTEDO XR or AUSTEDO, do not drive a car or operate dangerous machinery until you know how AUSTEDO XR or AUSTEDO affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking AUSTEDO XR or AUSTEDO may increase any sleepiness caused by AUSTEDO XR and 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).


The most common side effects of AUSTEDO XR are expected to be similar to AUSTEDO in people with Huntington’s disease or tardive dyskinesia.


These are not all the possible side effects of AUSTEDO XR or 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 Medication Guide available at AUSTEDO.com, or by calling 1-800-887-8100.

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REFERENCES:  1. AUSTEDO XR® (deutetrabenazine) extended-release tablets and AUSTEDO® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010. 3. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. 4. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 5. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13:773999. 6. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Supplementary appendix. Lancet Psychiatry. 2017;4(suppl 1):1-4. 7. Marder SR, Singer C, Lindenmayer JP, et al. A phase 3, 1-year, open-label trial of valbenazine in adults with tardive dyskinesia. J Clin Psychopharmacol. 2019;39(6):620-627. 8. Chaijale N, Bona J, Barkay H, Wilhelm A, Gordon MF. Deutetrabenazine reduces severe tardive dyskinesia movements in a 3-year open-label extension trial. Poster presented at: Neuroscience Education Institute (NEI) MAX! Virtual Congress; November 5-8, 2020. 9. Sajatovic M, Gandhi P, Konings M, et al. Long-term safety and efficacy of deutetrabenazine in patients aged ≥65 years with tardive dyskinesia. Poster presented at: American Association for Geriatric Psychiatry; March 14-17, 2025; Phoenix, AZ. 10. Sajatovic M, Alexopoulos GS, Jen E, et al. Improvements over time with valbenazine in elderly adults (≥65 Years) with tardive dyskinesia: post hoc analyses of 2 long-term studies. J Clin Psychiatry. 2025;86(2):24m15550. 11. Hauser RA, Barkay H, Fernandez HH, et al. Effects of long-term deutetrabenazine treatment in patients with tardive dyskinesia and underlying psychiatric or mood disorders. Poster presented at: Psych Congress; October 29-November 1, 2021; San Antonio, TX. 12. Fernandez HH, Stamler D, Davis MD, et al. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019;90(12):1317-1323. 13. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Supplement 1. Front Neurol. 2022;13(suppl 1):773999.