Teva Announces Largest-Ever Trial to Collect Information from Patients and Physicians About TD, its Impact and Progression Over Time, and Evaluate Treatment-Related Outcomes
3-Year Longitudinal Registry and Study to Assess the Impact of Tardive Dyskinesia and Real-World Use of AUSTEDO® (deutetrabenazine) Tablets Initiated
TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA),today announced the initiation of a 3-year longitudinal registry and study to assess the impact of tardive dyskinesia (TD) and real-world treatment patterns and outcomes. The Phase 4, multicenter, prospective, observational two-part study is the largest-ever study of its kind for TD and will collect information from both patients and physicians on TD. The study will evaluate how the condition progresses over time and impacts a person’s quality of life, as well as outcomes related to treatment with AUSTEDO (deutetrabenazine) tablets.
“TD is a chronic, highly debilitating condition that affects one in four people who take certain mental health treatments, yet the long-term impact, burden and treatment patterns in everyday clinical practice are not well understood,” said Richard Jackson, MD, an Assistant Clinical Adjunct Professor in the University of Michigan School of Medicine’s Department of Psychiatry and the study’s lead investigator. “This study aims to collect data to better understand how TD impacts a person’s daily life and how the condition changes over time. In addition, both patient- and clinician-reported outcomes will be captured to help determine the severity and multidimensional impact of TD on patients.”
An irreversible, chronic condition, TD causes a person to experience sudden, random movements in their face and other body parts.1 Whether symptoms are mild, moderate, or severe, the impact of TD can be significant. In fact, three out of four people who have TD say it severely impacts how they function, feel, and interact with others.2,3
“We are proud to announce the initiation of this important study on TD during Mental Illness Awareness Week – a time dedicated to raising awareness of mental illness and stigma and highlighting the reality of living with a mental health condition,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “At Teva, we are deeply committed to improving the lives of patients and families impacted by mental illness and ensuring that scientific innovation is as focused on mental health as it is on physical health. We hope this study will shed light on both the impact of TD and care strategies that can help improve outcomes for patients, as we know TD can disrupt patients’ underlying mental health treatment plan.”
The study will be conducted in two parts:
- Part A (Registry) will collect information from TD patients about their condition, its impact and effect across domains including social, psychological and physical function, and how TD progresses over time.
- Part B (IMPACT-TD) will include a subset of patients from the Registry who initiate treatment with AUSTEDO to evaluate its effect on impact with a new clinician-reported measure, a 4-domain clinical scale, which was developed by an independent expert consensus panel sponsored by Teva, and a TD-specific patient-reported measure, which was validated for content relevancy by individuals with TD and caregivers. Approximately 600 patients aged 18 and older who have TD and meet the study’s eligibility requirements are expected to be enrolled in the Registry and will be evaluated at roughly 45 participating centers across the United States. Interested investigators that want to participate in the study, can visit https://www.impact-td-registry.com/ or contact impactTD@IQVIA.com for further information.
About AUSTEDO (deutetrabenazine) Tablets
AUSTEDO is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. TD is a movement disorder that is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals. Safety and effectiveness in pediatric patients have not been established.
Indications and Usage
AUSTEDO (deutetrabenazine) tablets is indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.
IMPORTANT SAFETY INFORMATION
Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
Contraindications: AUSTEDO is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO is also contraindicated: in patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®).
Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.
QTc Prolongation: AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO is administered within the recommended dosage range. AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS),a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
Parkinsonism: AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO.
Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.
Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.
Please see accompanying full Prescribing Information, including Boxed Warning.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of AUSTEDO; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
1 Lerner PP, et al. Psychiatry Clin Neurosci 2015;69:321–34
2 Tardive dyskinesia. MHA website. https://www.mhanational.org/conditions/tardive-dyskinesia. Accessed September 2022.
3 Jain R, et al. Presented at Psych Congress Annual Meeting; Oct 29–Nov 1, 2021; San Antonio, TX, USA
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