Findings Published in The American
Journal of Geriatric Psychiatry
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced results from
a post hoc analysis of a long-term, 3-year open-label extension
(OLE) study examining efficacy and safety endpoints for the use of
AUSTEDO (deutetrabenazine) tablets in younger (<55 years) and
older (≥55 years) patients with tardive dyskinesia (TD). The
findings, published online in The American Journal of Geriatric
Psychiatry, evaluated the long-term use of AUSTEDO with the total
motor Abnormal Involuntary Movements Scale (AIMS) score, and
measures of treatment success and quality of life.
TD affects about 500,000 people in the United States and
approximately 25 percent of the global population taking first-and
second-generation antipsychotics.1,2 It is usually a result of
prolonged use of treatments that block dopamine receptors in the
brain, such as antipsychotics commonly prescribed to treat mental
illnesses like schizophrenia, bipolar disorder and depression, as
well as certain anti-nausea medications. Notably, TD incidence
rates are estimated to be three to five times higher in patients
over 50 years old.3
“This analysis helps further our understanding of AUSTEDO as a
treatment that may help alleviate uncontrolled movements in adults
but is particularly compelling when considering treatment of older
patients,” said Martha Sajatovic, MD, University Hospitals
Cleveland Medical Center at Case Western Reserve University School
of Medicine in Ohio. “Symptoms of TD can worsen in severity over
time, especially in patients 55 years and older who have had
long-term treatment with an antipsychotic prescription. As this
occurs, they may experience balance and coordination issues,
putting them at an increased risk for falls that may be especially
concerning.”
This post hoc analysis was conducted to potentially inform
treatment decisions in younger and older patients with TD treated
with deutetrabenazine. Data were derived from the single-arm 3-year
OLE study in patients that had successfully completed either the
Phase 3 ARM-TD or AIM-TD study (n=337). The safety profile of
AUSTEDO was generally similar across both the younger and older
patients. Due to the uncontrolled nature of the data and post hoc
analysis, no determination of statistical significance can be
made.
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 tardive dyskinesia in adults 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 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.
# # #
1 Tardive Dyskinesia Information Page. National Institute of
Neurological Disorders and Stroke.
https://www.ninds.nih.gov/Disorders/All-Disorders/Tardive-Dyskinesia-Information-Page.
Accessed August 12, 2021 2 Carbon, M, Hsieh, C-H, Kane, JM, et al.
Tardive dyskinesia prevalence in the period of second-generation
antipsychotic use: a meta-analysis. Journal of Clinical Psychiatry.
2017;78(3): e264–78. 3 Woerner MG, Alvir JMaJ, Saltz BL, et al.,
Prospective study of tardive dyskinesia in the elderly: rates and
risk factors. Am J Psychiatry. 1998; 155: 1521–1528.
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IR Contacts United States Kevin C. Mannix, (215)
591-8912 Yael Ashman, 972 (3) 914-8262
PR Contacts United States Doris Yiu, (973) 265-3752
Yonatan Beker, (973) 917-0851
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