Call to Action: Teva Dedicated to Improving Lives of Patients Suffering from Tardive Dyskinesia (TD)

Sponsored by Teva Neuroscience, Inc.

A Look at the Impact of Tardive Dyskinesia from a Patient’s Perspective

Sherland has been living with major depression and bipolar disorder for seven years. In 2018, she developed tardive dyskinesia (TD), a chronic movement disorder typically caused by certain medications used to treat mental health disorders.^1,2

The condition is characterized by mild to severe involuntary blinking, tongue or other unintentional body movements that may impact a person’s ability to perform tasks in their daily lives like talking, eating, walking or even taking care of themselves.^1,3,4 As Sherland began experiencing the onset of TD, she saw its impact on not just her but the people in her life, and it was jarring.

“When I started experiencing TD symptoms, my jaw would quiver, and the left side of my mouth would sag when I spoke – slurring my speech,” said Sherland. “People would ask me when I had a stroke, but it wasn’t until my daughter asked me what was wrong with my mouth that I finally understood something was wrong.”

For Sherland, not knowing what was going on with her body was frightening and made her feel isolated from the world.

“There’s no way to explain the shame that comes with not knowing what’s wrong with you. Finally, when I visited my mental health doctor, and I was diagnosed with TD, I was able to feel hopeful that I could finally put a name to what was going on and that I didn’t have to live like this.”

Sherland is just one of the 785,000 people in the United States estimated to be living with TD (with more than 80% still not treated), and has experienced firsthand the emotional toll that can come with it.⁵ Yet unlike the majority, she received a formal TD diagnosis from her doctor and started treatment for her TD.

Measuring the Impact of TD and the Importance of a Treatment Plan

For many people living with TD, the psychological, social, and vocational impact can be substantial even when the physical movements are mild or moderate. Since TD is typically irreversible, the development and evolution of this disorder can be a huge setback for patients who have worked so hard to achieve psychiatric stability.⁶ Despite the onset of TD, many patients do not get approved treatments to address this condition – with only around 5% receiving available treatments – even though TD management is a key component in the overall management of mental health disorders.⁵

In a survey assessing patients taking antipsychotic medications who reported involuntary muscle movements, 35.7% stopped going to the doctor to treat their underlying condition and 39.3% stopped taking their antipsychotic medication altogether following the development of TD,⁷ further demonstrating the detrimental impact TD can truly have on patients’ overall wellbeing, and requiring a call to action to see the majority of the 785,000 patients receive diagnoses and treatment for the compromising impact due to mental health medication.⁵

Like many living with TD, Sherland is not alone when recalling the social and psychological impact the onset of TD has had on her life. For nearly 50 years, the medical community has been using the Abnormal Involuntary Movement Scale (AIMS). While this rating scale measures the physical evolution of TD, it does not truly evaluate the full impact living with TD can have on one’s life.⁸

Recognizing this gap, Teva Pharmaceuticals sponsored a consensus panel with nine healthcare providers that led to the development of the IMPACT-TD scale, which provides a standardized approach to the measurement of social, vocational, educational, recreational, psychological, psychiatric and physical challenges resulting from TD that need to be taken into account by both patients and physicians.⁸

Just as it is important to assess the impact of TD, accounting for TD in a patient’s overall mental health treatment plan is also crucial for long-term treatment success.

“My experience with TD has made me so much more grateful about life and has changed my perspective on my mental health journey too,” said Sherland. “TD is a treatable condition and it’s so important to take care of your TD in parallel with your mental health – you don’t need to make a choice.”

Once-Daily Treatment Option Available in the U.S. for Adults Living with TD

Once-daily AUSTEDO® XR (deutetrabenazine) is an available treatment option for people living with TD, which was approved by the U.S. Food and Drug Administration in February 2023. AUSTEDO XR has been shown to be therapeutically equivalent to the original twice-daily formulation, AUSTEDO^® (deutetrabenazine).⁵ Patients and their doctors can therefore expect the same rapid TD symptom control as early as two weeks, with results sustained across three years in the longest TD trial to date. ^5,9-12

Importantly, the once-daily formulation can be taken with or without food and is available in three different strengths (6 mg, 12 mg, and 24 mg). AUSTEDO XR is also indicated for chorea associated with Huntington’s disease (HD), a symptom of this progressive, genetic and neurodegenerative disorder that causes uncontrollable muscle movements and affects an estimated 90% of people living with HD.¹³

AUSTEDO XR along with its twice-daily counterpart, AUSTEDO, are the only vesicular monoamine transporter 2 (VMAT2) inhibitor TD treatments with no restrictions for use alongside CYP3A4/5 inducers or inhibitors, an important consideration for patients who take a variety of concomitant medications to manage their underlying conditions.^14,15 Further, in the pivotal studies most patients taking AUSTEDO were able to stay on their concomitant psychiatric medications.¹⁵

Having a once-daily option in the form of AUSTEDO XR gives patients the option to transition over to this formulation with confidence that they know they are receiving the same proven treatment as the twice-daily AUSTEDO formulation.

As someone who continues to count on AUSTEDO for symptom control, Sherland has experienced firsthand how it is possible to manage her TD symptoms and focus on her family and passions. She hopes more people like herself who are living with TD will have the opportunity to do the same.

“There is a misconception that there’s nothing you can do about your TD and it’s just something you need to live with,” said Sherland. “Since starting AUSTEDO to manage my TD, I have seen an improvement in my symptoms, and for those currently struggling with TD, I encourage them to take the step to speak with their doctors about managing their symptoms.”

To learn more about how AUSTEDO XR could help your patients with TD or HD chorea, click here.

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 accompanying full Prescribing Information, including Boxed Warning.

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1 Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic drugs. Hauppauge, NY: Nova Science Publishers. 2013:235-258.

2 Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11. 3. Sharing the impact of tardive dyskinesia.

3 Tardive dyskinesia. National Alliance on Mental Illness. Published March 2019. Accessed March 23, 2023. https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Tardive-Dyskinesia

4 Sharing the impact of tardive dyskinesia. National Alliance on Mental Illness website. http://notalone.nami.org/post/97568253959/sharing-the-impact-of-tardive-dyskinesia. Accessed May 7, 2020.

5 Data on file. Parsippany, NJ: Teva Neuroscience, Inc.

6 Cornett, E. M., Novitch, M., Kaye, A. D., Kata, V., & Kaye, A. M. (2017). Medication-Induced Tardive Dyskinesia: A Review and Update. The Ochsner journal, 17(2), 162–174.

7 Jain R, Ayyagari R, King S, Edwards GG, Wilhelm A, Leo S. Impact of tardive dyskinesia on physical, psychological, and social aspects of patient lives: a survey of patients and caregivers in the United States. Presented at: Psych Congress 2021; October 29–November 1, 2021; San Antonio, TX

8 Jackson, R., Brams, M. N., Carlozzi, N. E., Citrome, L., Fritz, N. E., Hoberg, A. R., Isaacson, S. H., Kane, J. M., & Kumar, R. (2022). Impact-Tardive Dyskinesia (Impact-TD) Scale: A Clinical Tool to Assess the Impact of Tardive Dyskinesia. The Journal of clinical psychiatry, 84(1), 22cs14563. https://doi.org/10.4088/JCP.22cs14563
9 Hauser, R. A., Barkay, H., Fernandez, H. H. et al. Long-Term Deutetrabenazine Treatment for Tardive Dyskinesia is Associated with Sustained Benefits and Safety: A 3-Year, Open-Label Extension Study. Frontiers in Neurology (2022). https://doi.org/10.3389/fneur.2022.773999.

10 Anderson K. E., Stamler D., Davis M. D., et al. Deutetrabenazine for the treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomized, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604

11 Fernandez HH, Factor SA, Hauser RA, et al. Randomised controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010.

12 Marder S. R., Singer C., Lindenmayer J-P., 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.

13 Thorley, E. M., Iyer, R. G., Wicks, P., Curran, C., Gandhi, S. K., Abler, V., Anderson, K. E., & Carlozzi, N. E. (2018). Understanding How Chorea Affects Health-Related Quality of Life in Huntington Disease: An Online Survey of Patients and Caregivers in the United States. The patient, 11(5), 547–559. https://doi.org/10.1007/s40271-018-0312-x

14 AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets [current approved prescribing information].Parsippany, NJ: Teva Neuroscience, Inc

15 AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc.

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