ARM-TD: Change in AIMS Total Score From Baseline to Week 12 (N=113; P=0.019)2
in TD severity at Week 12 vs placebo
Study used response-driven dosing approach: Patients titrated to effective and tolerable symptom control.1,2
Majority of patients achieved significant AIMS score reduction
AIM-TD: Change in AIMS Total Score From Baseline to Week 12 (N=222)1,3
in TD severity with AUSTEDO
36 mg/day vs placebo1,3
Primary Endpoint: Change in AIMS total score from baseline to Week 12
Mean baseline AIMS score:
Patients who completed ARM-TD or AIM-TD were eligible to roll over into the long-term open-label extension study (RIM-TD).5
Primary Endpoint: Change in AIMS total score from baseline to Week 12 in 36 mg/day arm vs placebo
Mean baseline AIMS score:
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
Rapid response as early as Week 22,3*
AIMS Score Reduction in Pivotal and OLE Studies2,4,5
Tolerability comparable to pivotal trials, with no new safety signals.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
The only VMAT2 inhibitor with consistent results over 3 years in patients at increased risk for TD4,5,7,9-11:
Data from post hoc analyses of the RIM-TD study.
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
Similar dose and response at 3 years (>36 mg/day)¶
Similar safety and tolerability profile
Similar percentage of patients remained in the study at 3 years
||In a post hoc subgroup analysis of RIM-TD.
¶Mean total dose.
Sustained results across 3 years in postmenopausal patients#**
#In a post hoc subgroup analysis of RIM-TD.
**Postmenopausal defined as being amenorrheic for ≥1 year with a serum follicle
stimulating hormone level consistent with postmenopausal status.
††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
‡‡The mood disorder subgroup included patients with bipolar disorder and depression.
§§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 schizophrenia
Schizophrenia Subgroup||||: AIMS Score Reduction in RIM-TD
||||The schizophrenia subgroup included patients with schizophrenia and schizoaffective disorder.
¶¶Mean total dose.
See a long-term care resident’s journey with TD movement improvement
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.
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.
DRA, dopamine-receptor antagonist.
Plasma Concentration Over 96 Hours: AUSTEDO XR 48 mg vs AUSTEDO XR 2×24 mg QD##
##Based on active alpha and beta metabolites.
Plasma Concentration at Steady State Over 24 Hours: AUSTEDO XR vs BID†††
***Data support bioequivalence of XR and BID across the full dosing range of AUSTEDO.
†††Based on active alpha and beta metabolites.
Patients in the pivotal and RIM-TD studies received the AUSTEDO BID formulation.1,5
OLE, open-label extension.1
*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
In a real-world survey of 209 patients with TD taking AUSTEDO XR, the majority of patients reported movement reduction (>90%)4
Emotional well-being4
Social well-being4
Physical well-being &
Consistent results across 
Movement improvement with AUSTEDO XR (>94%)
Increased comfort in social settings and improved emotional well-being as a result of movement reduction with AUSTEDO XR (>77%)
Taking AUSTEDO XR is easy (>96%)
Liking that their doctor has the ability to adjust their dose (≥82%)
*Consistent survey results across patients previously treated with valbenazine (n=54) or with no prior TD treatment (n=100).
No head-to-head studies comparing deutetrabenazine and valbenazine have been conducted. These patient survey results should not be construed to imply differences in safety, efficacy, or clinical outcome.
See how AUSTEDO XR made a difference in this
patient's daily life
Onscreen text:
MOVEMENT CONTROL
MADE POSSIBLE
RACHEL’S JOURNEY WITH TD AND
SCHIZOPHRENIA
Disclaimer at bottom of screen:
This was an individual patient’s experience. Results may vary. Participant was compensated by Teva Pharmaceuticals.
>TD, tardive dyskinesia.
Rachel:
Hi, I’m Rachel—I’m a grandma and a mother.
When I was 18, I was diagnosed with schizophrenia.
I would spend months in the hospital…and it just went on for years.
On-screen text:
After being on antipsychotic medication for 16 years, Rachel began experiencing involuntary movements.
Rachel:
I noticed it first in my hands and then I started getting very upset when it started going to my face because people were not very kind.
You know, at that point, my hands were like this.
…All day my tongue just kept sticking out of my mouth, sticking out of my mouth.
I lost the feeling in my legs…my legs wouldn't hold my body anymore…and it just got so bad.
For the longest time, I didn't want to go outside. I was too ashamed to go outside…I was too ashamed to go and talk to people and be around people because the movements, they were so embarrassing.
That really hurt my feelings, was the cruelness people had towards me with making fun of me.
“Why are you talking like that, you sound drunk…why is your tongue sticking out, why are you walking like that.”
I went to the doctor and I pleaded with her. I told her, please listen to me. Something's going on with me.
On-screen text:
After struggling with movements for several years, Rachel was finally diagnosed with TD.
Her doctor started her on AUSTEDO XR, and she soon began to notice a difference.
Onscreen Indication and Black Box Warning:
AUSTEDO XR® and AUSTEDO® 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.
Please see additional Important Safety Information at the end of this video.
Rachel:
When I was diagnosed with the tardive dyskinesia…it finally gave a name to something that I didn’t know.
When I started taking the AUSTEDO…my hands started smoothing out where they weren’t tapping so much…
And then I noticed that my tongue started to stay in my mouth more.
AUSTEDO lessened…my movements so much that I was just stunned. And I couldn't believe it.
Onscreen text:
In pivotal studies, patients like Rachel saw significant reduction of TD severity at Week 12.
Onscreen text:
3 YEARS of results
Sustained results through 3 years observed in TD patients with schizophrenia (open-label extension study).*
Footnote at bottom of screen:
*Post hoc subgroup analysis.
Rachel:
With less TD movements, I’m able to do more things now.
I can make bracelets with my beadwork. I can do my woodwork. I can go and play with the kids. I can go for walks now.
I can hold my own cup. I can brush my teeth. I can clean the house. I can drive again.
Footnote at bottom of screen:
AUSTEDO XR has not been shown to affect the outcomes mentioned.
Rachel:
It’s important to know about my story because there's so many people out there that have it and they're ashamed.
You know, TD is not your fault. You can do something about it, like I did. You can ask your doctor for medication.
Footnote at bottom of screen:
AUSTEDO XR has not been shown to affect the outcomes mentioned.
Rachel:
It took everything and turned it around and made me be able to be alongside of people again.
It made me feel that there's hope.
Onscreen text:
How can AUSTEDO XR make a difference for your patients?
Learn more at AUSTEDOhcp.com
Onscreen ISI scroll:
INDICATIONS AND USAGE
AUSTEDO XR and AUSTEDO 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, at AUSTEDOhcp.com.
Improvement Over Time
See Charlene’s symptom
improvements with AUSTEDO over 5+ years 
Onscreen text:
Age: 68
Primary condition: Schizoaffective disorder
MARCH 2020
SEPTEMBER 2020
JUNE 2022
NOVEMBER 2025
48 mg/day
Disclaimer at bottom of screen:
This was an individual patient’s experience. Results may vary. Participants were compensated by Teva Pharmaceuticals.
Onscreen text:
MARCH 2020
Before AUSTEDO
NOVEMBER 2025
AUSTEDO 48 mg/day
“You can be on AUSTEDO® long term and not have to fight the twitching all your life, and that’s so much better than not being around people.”
– CHARLENE
Disclaimer at bottom of screen:
No clinical trials have been conducted to suggest that AUSTEDO affects the outcomes mentioned.
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.
Please see additional Important Safety Information at the end of this video.
Onscreen text:
CHARLENE’S JOURNEY OVER 5+ YEARS
Onscreen text:
MARCH 2020
Before AUSTEDO
AIMS TOTAL SCORE: 10
When Charlene developed TD, she was told her involuntary movements would last forever. But she wasn’t ready to give up…
Onscreen text:
SEPTEMBER 2020
24 mg/day
AIMS TOTAL SCORE: 4
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?”
– CHARLENE’S DOCTOR
“I think there’s room for improvement.”
– CHARLENE
Onscreen text:
AUSTEDO
36 mg/day
As her dose was increased, Charlene’s movements continued to improve.
“Your movements look better…your fingers look pretty stable…”
– CHARLENE’S DOCTOR
“Yeah, and my mouth isn’t going 20 miles per hour…”
– CHARLENE
Onscreen text:
JUNE 2022
AUSTEDO 48 mg/day
At her maintenance dose of 48 mg/day, Charlene continues to see effective and tolerable symptom control.
“After a little over 2 years on AUSTEDO...my feet aren’t moving all the time. My hands aren’t moving all the time.”
– 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
Onscreen text:
NOVEMBER 2025
AUSTEDO 48 mg/day
More than 5 years after starting AUSTEDO, Charlene’s movement control helps her live life more fully.
“Now I’m not by myself all the time hiding out...”
– CHARLENE
“AUSTEDO has worked for my patient for many years, and the movement reduction has improved her self-confidence.”
– CHARLENE’S DOCTOR
[Disclaimer at bottom of screen]
No clinical trials have been conducted to suggest that AUSTEDO affects the outcomes mentioned.
Onscreen text:
MARCH 2020
Before AUSTEDO
NOVEMBER 2025
AUSTEDO 48 mg/day
What could long-term results mean for your patients like Charlene?
SEE THE REST OF CHARLENE’S STORY AT AUSTEDOHCP.COM
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.
Learn more about AUSTEDO XR at AUSTEDOhcp.com
Please see full Prescribing Information, including Boxed Warning, at AUSTEDOhcp.com.
Sherland Shares Her Truth About TD
Learn how treatment with AUSTEDO over 4+ years got Sherland back to what she loved
For more videos, visit
the YouTube page.
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.
For more videos, visit
the YouTube page.
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. 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. 11. Nasrallah H, Chen M, Barkay H, Gordon MF, Finkbeiner S. Long-term efficacy and safety of deutetrabenazine in postmenopausal women with tardive dyskinesia. Poster presented at: American Psychiatric Association; May 21–25, 2022; New Orleans, LA. 12. 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. 13. 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. 14. 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. 15. Jain R, Konings M, Driessen MT, Kotak S, Gandhi P. Patient experience with once-daily deutetrabenazine extended-release tablets for the treatment of tardive dyskinesia in individuals with prior valbenazine use. Poster presented at: Psych Congress 2025; September 17-21, 2025; San Diego, CA.
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