New Phase 3 RISE study data, post hoc analyses and open-label extension studies to be presented underscore company’s heritage in and commitment to mental health and neuroscience
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 25 presentations examining new Phase 3 clinical data, post hoc analyses and open-label extension (OLE) studies for both TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) and AUSTEDO® (deutetrabenazine) tablets. Study findings will be presented at the upcoming 2021 Psych Congress Annual Meeting taking place Oct. 29-Nov. 1, 2021 in San Antonio, TX (in addition to virtual participation).
These data underscore Teva’s commitment to addressing the current unmet needs in managing mental illness. Combining creativity, scientific rigor and extensive knowledge on a broad range of technologies, Teva is working to not only uncover the full potential of existing medications, but to also provide new treatment options to support the management of neurological and psychiatric disorders like schizophrenia and tardive dyskinesia (TD).
“Those living with a serious mental illness face and overcome challenges every day, and we are committed to the advancement of science in mental health,” said Matthias Mueller, MD MSc, VP Global Medical Affairs at Teva. “We continue to build upon our heritage in mental health through the development and delivery of medicines that help address the real-world challenges faced by this community of patients and providers.”
Data presentations at this year’s Psych Congress evaluate the efficacy and safety profiles of investigational TV-46000, a subcutaneous risperidone injectable suspension being studied for the treatment of patients with schizophrenia. Presentations describe improvements in patient-centered outcomes, symptoms over time, as well as patient and healthcare professional choice and treatment experiences with TV-46000. Additional data that will be featured during the congress examine the physical,psychological and social impacts of TD on patients and caregivers, as well as explore the efficacy, safety and dosing patterns of long-term treatment with AUSTEDO® in patients with TD.
Data to be presented include:
- Efficacy and Safety of Subcutaneous Risperidone Injectable (TV-46000) in Patients With Schizophrenia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study (RISE Study)
- TV-46000, a Long-Acting Subcutaneous Risperidone Injectable, Demonstrated Improved Patient-Centered Outcomes in Patients With Schizophrenia
- TV-46000 Provided Continued Symptom Improvement in Patients With Schizophrenia During the Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention RISE Study
- Robustness of TV-46000 Efficacy Data from RISE: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study in Patients With Schizophrenia
- Behavioral-, Metabolic-, Endocrine-, and Cardiovascular-Related Adverse Events in Patients With Schizophrenia Treated With TV‐46000
- Efficacy and Safety of TV-46000, Subcutaneous Long-Acting Injectable Risperidone, by Injection Site (Upper Arm, Abdomen): Post Hoc Analysis of the Phase 3 RISE Study
- Contingency Planning and Risk Mitigation Strategies for a Schizophrenia Relapse Prevention Trial During the COVID-19 Pandemic
- Annual Schizophrenia-Related Medical Resource Utilization and Costs Among Patients in the United States Utilizing Atypical Antipsychotic Agents: An Analysis of a Commercial Claims Database
- Treatment Patterns Among Patients in the United States Utilizing Long-Acting Injectable Antipsychotic Agents: An Analysis of a Commercial Claims Database
- Retrospective Analysis of a Commercial Claims Database for Predictors for Initiation of Atypical Long-Acting Injectable Antipsychotic Agents
- Patient Preferences and Treatment Experiences With TV-46000, a Long-Acting Subcutaneous Injectable Risperidone Formulation
- Health Care Professional Preferences and Treatment Experiences With TV-46000, a Long-Acting Injectable Risperidone Formulation
- Determination of Flexible Dose Regimens for TV-46000, a Risperidone Extended Release Suspension for Subcutaneous Injection in Development for the Treatment of Schizophrenia
- Exposure-Response Analysis to Assess the Relationships Between TV‑46000 Pharmacokinetic Exposure Parameters, Prevention of Impending Relapse and Adverse Events
- Network Meta-Analysis of Cohort Studies Involving Oral and Long-Acting Injectable Antipsychotic Agents: Administration Frequency and Incidence Rate of Hospitalization in Schizophrenia
- Association of Oral and Long-Acting Injectable Antipsychotic Administration Frequency With Odds of Hospitalization in Schizophrenia: Network Meta-Analysis of Cohort Studies
- Long-Term Efficacy and Safety of Deutetrabenazine in Patients with Tardive Dyskinesia by Concomitant Dopamine-Receptor Antagonist Use
- Effects of Long-Term Deutetrabenazine Treatment in Patients with Tardive Dyskinesia and Underlying Psychiatric or Mood Disorders
- Dose Patterns for Long-Term Deutetrabenazine Treatment in Patients With Tardive Dyskinesia by Baseline Abnormal Involuntary Movement Scale Item 8 Score
- Impact of Tardive Dyskinesia on Physical, Psychological, and Social Aspects of Patient Lives: A Survey of Patients and Caregivers in the United States
- Caregiver Burden of Tardive Dyskinesia in the United States: A Survey of Impact on Caregiving Tasks, Psychological Well-Being, and Daily Activities
- A Retrospective, Scoping Review of Unstructured Electronic Medical Record Data of Patients with Tardive Dyskinesia
- Incidence of Adverse Events Associated With Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated with Huntington’s Disease
- Evaluation of the QTc Prolongation Risk of Deutetrabenazine
- Effects of VMAT2 Inhibitors on Extracellular Levels of Dopamine, Norepinephrine, 5-HT and Histamine in the Striatum and Medial Prefrontal Cortex: A Dual-Probe Microdialysis Study in Awake Rats
Data presentations can be accessed by registering for the meeting.
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts. Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability. Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition. Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women. The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization. Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology. Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.
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 for the treatment of adults with tardive dyskinesia and 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.
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 of risperidone LAI and 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 its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general, 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 Annual Report on Form 10-K for the year ended December 31, 2020, 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.
Kevin C. Mannix (215) 591-8912
Yael Ashman 972 (3) 914-8262
Doris Li (973) 265-3752
Yonatan Beker (973) 917-0851