Three posters evaluate the long-term safety and
efficacy of AUSTEDO® (deutetrabenazine) tablets as well as the
physical, psychological, and social impact of tardive dyskinesia on
patients
One study explores the innovative copolymer
technology of TV-46000, an extended-release injectable suspension
being investigated for the treatment of schizophrenia
Teva will sponsor two educational sessions,
examining how social determinants of mental health relate to
neuropsychiatric disorders and on the clinical value of long-acting
injectables in schizophrenia treatment
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced four data
presentations for AUSTEDO® (deutetrabenazine) tablets and
TV-46000/mdc-IRM. These data will be presented at the American
Psychiatric Association (APA) Annual Meeting held May 21-25, 2022
in New Orleans, Louisiana, and again virtually June 7-10, 2022.
Featured data at this year’s APA Annual Meeting include findings
from a study evaluating long-term treatment with AUSTEDO in
postmenopausal women with tardive dyskenisia (TD), as well as two
surveys examining the impact of TD on physical, psychological and
social aspects of patients’ lives. Teva will also showcase data on
an innovative copolymer technology under license from MedinCell
that controls the steady release of risperidone in TV-46000, a
risperidone extended release injectable suspension formulation.
“We are excited to be back at APA live and in person during
Mental Health Awareness Month this year to continue compelling
dialogue about unmet need across the mental health spectrum and
Teva’s role in helping to meet those needs,” said Denisa Hurtukova,
MD, VP, Head of North America Medical Affairs. “Our evolving
clinical program across diseases of the central nervous system and
mental health conditions underscores our ongoing commitment to
advancing science for real-world solutions for neurological and
psychiatric disorders.”
Teva will also be holding a presentation titled, “Making a
Difference for Patients With Tardive Dyskinesia (TD): Proactively
Recognizing and Treating an Overlooked Disorder” on Monday, May 23,
2022, from 7:15-8:30 PM CT live at the Hilton New Orleans Riverside
and virtually. Expert faculty, Drs. Leslie Citrome and Andrew
Cutler, will be discussing the impact that TD can have on patients
and the barriers to diagnosis and treatment. This program will also
underscore the importance of HCP-patient communication in further
uncovering how TD can impact patients’ lives, as well as explore
techniques for virtual assessments in screening for TD and clinical
data on the efficacy and safety of AUSTEDO in the treatment of
adults with TD.
Teva will also host two sponsored in-person sessions:
- “How the Social Determinants of Mental Health Relate to
Neuropsychiatric Disorders: What Can We Do About Them in Clinical
Practice?”
- When: Saturday, May 21, 3:00 PM CT
- Where: Product Showcase #2, Booth #3414
- Featured speakers: Michael Compton, MD, MPH, DFAPA, Cynthia
Armand, MD, Craig Chepke, MD, FAPA
- What: Social determinants and social consequences associated
with neuropsychiatric disorders, including how to best manage and
support patients to protect their mental health and optimize health
outcomes.
- “Long-Acting Injectables in Schizophrenia: Dispelling Myths,
Unlocking Clinical Value”
- When: Monday, May 23, 2:00 PM CT
- Where: Product Showcase #2, Booth #3414
- Featured speakers: John Kane, MD, Leslie Citrome, MD, Christoph
Correll, MD, Jose Rubio, MD
- What: Featured speakers will provide insight into the value of
LAIs and benefits of early adoption, before introducing a resource
and framework to address clinical dilemmas that may result from
common LAI myths.
Teva will also be hosting Meet-the-Expert sessions at Teva’s
Medical Affairs booth, #1533, with three expert speakers from the
two Teva-sponsored sessions at the following times:
- Leslie Citrome, MD: Sunday, May 22, 3:00 – 3:30 PM CT
Sunday, May 22, 3:30 – 4:00 PM CT
- Christoph Correll, MD: Saturday, May 21, 1:00 – 1:30 PM
CT Monday, May 23, 3:30 – 4:00 PM CT
- Craig Chepke, MD: Saturday, May 21, 4:30 – 5:00 PM CT
Monday, May 23, 9:30 – 10:00 AM CT
Posters are available online and can be accessed via the APA
meeting website at: www.psychiatry.org/annualmeeting.
The full set of data sponsored by Teva include:
AUSTEDO:
De novo:
- [Poster #P5-034] Long-Term Efficacy and Safety of
Deutetrabenazine in Postmenopausal Women With Tardive
Dyskinesia
- [Poster #P7-082] Impact of Tardive Dyskinesia on
Physical Aspects of Patient Lives: A Survey of Patients and
Caregivers in the United States
- [Poster #P7-083] Impact of Tardive Dyskinesia on
Psychological and Social Aspects of Patient Lives: A Survey of
Patients and Caregivers in the United States
TV-46000:
De novo:
- [Poster #P8-078] Characterization of novel drug delivery
technology utilized in TV-46000, a risperidone extended-release
injectable suspension formulation
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.
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 TV-46000/mdc-IRM
TV-46000/mdc-IRM is an investigational long-acting subcutaneous
atypical antipsychotic injection being explored for the treatment
of schizophrenia. TV-46000 is a subcutaneous, long-acting
formulation of risperidone that utilizes a copolymer technology
under license from MedinCell that controls the steady release of
risperidone and allows for rapid absorption and sustained release
via a subcutaneous injection.
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,
biosimilar 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; the development of TV-46000/mdc-IRM;
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 first 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.
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