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:
TV-46000:
De Novo
- 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
Encore
- 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
AUSTEDO:
De Novo
- 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
Encore
- 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.
About Schizophrenia
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.
About Teva
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.
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IR Contacts United States Kevin C. Mannix (215)
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PR Contacts United States Doris Li (973) 265-3752
Yonatan Beker (973) 917-0851
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