3-Year Longitudinal Registry and Study to
Assess the Impact of Tardive Dyskinesia and Real-World Use of
AUSTEDO® (deutetrabenazine) Tablets Initiated
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.
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 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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