Three abstracts evaluate the long-term safety and efficacy of AUSTEDO®
(deutetrabenazine) tablets for the treatment of tardive
dyskinesia in adults
In addition, new health economics data assess quality of life and
health burden impact among patients
JERUSALEM--(BUSINESS WIRE)--May 2, 2018--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced new scientific abstracts for AUSTEDO®
(deutetrabenazine) tablets will be presented at the American Psychiatric
Association (APA) 2018 Annual Meeting in New York from May 5-9. The
studies shared at the meeting continue to grow the comprehensive body of
data supporting the safety and efficacy of AUSTEDO®.
“We are eager to share our research at this prestigious meeting with the
psychiatry community who help identify, treat and manage patients with
tardive dyskinesia,” said Tushar Shah, M.D., Senior Vice President, Head
of Specialty Clinical Development at Teva. “Tardive dyskinesia exacts a
considerable burden on patients, and we are excited to share studies
providing insights to help these patients.”
The Teva-sponsored data to be presented includes:
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[P6.137] Measuring the Health Status Burden of Tardive Dyskinesia
(Poster Session 6, May 7, 2018, 2:00-4:00 p.m. ET)
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[P6.138] Predictors of Tardive Dyskinesia in Psychiatric Patients
Taking Concomitant Antipsychotics (Poster Session 6, May 7, 2018,
2:00-4:00 p.m. ET)
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[P6.139] Long-Term Improvements in Site-Rated Outcomes with
Deutetrabenazine Treatment in Patients with Tardive Dyskinesia
(Poster Session 6, May 7, 2018, 2:00-4:00 p.m. ET)
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[P6.140] Long-Term Deutetrabenazine Treatment in Tardive Dyskinesia
by Concomitant Dopamine-Receptor Antagonists and Baseline Comorbidities
(Poster Session 6, May 7, 2018, 2:00-4:00 p.m. ET)
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[P6.141] Long-Term Treatment with Deutetrabenazine Improves Quality
of Life in Patients with Tardive Dyskinesia as Assessed by a Modified
Dystonia Scale (Poster Session 6, May 7, 2018, 2:00-4:00 p.m. ET)
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[P8.116] Hospital Utilization Rates Following Antipsychotic Dose
Reductions Among Patients with Bipolar and Major Depressive Disorders
(Poster Session 8, May 8, 2018, 2:00- 4:00 p.m. ET)
About Tardive Dyskinesia
Tardive dyskinesia (TD) is a disorder that results in involuntary,
repetitive body movements.1 This may include grimacing,
sticking out the tongue or smacking of the lips.1
Additionally, there may be rapid jerking movements or slow writhing
movements.1 In about 20 percent of people, decreased
functioning results.2 The condition affects up to 500,000
people in the United States and can be caused by certain medications
used to treat mental health conditions or gastrointestinal conditions.3,4
About AUSTEDO® (deutetrabenazine)
AUSTEDO® is a 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. Safety and effectiveness in
pediatric patients have not been established.
Important Safety Information
AUSTEDO® can increase the risk of depression
and suicidal thoughts and behavior (suicidality) in patients with
Huntington’s disease. Anyone considering the use of AUSTEDO® must
balance the risks of depression and suicidality with the clinical need
for treatment of chorea. 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®).
AUSTEDO® may cause a worsening in mood, cognition, rigidity,
and functional capacity in patients with Huntington’s disease.
Tetrabenazine (a closely related VMAT2 inhibitor) causes an increase in
the corrected QT (QTc) interval. A clinically relevant QT prolongation
may occur in some patients treated with AUSTEDO® who are
CYP2D6 poor metabolizers or are co-administered a strong CYP2D6
inhibitor or other drugs that are known to prolong QTc. Neuroleptic
Malignant Syndrome has been observed in patients receiving
tetrabenazine. AUSTEDO® may increase the risk of akathisia,
agitation, and restlessness. AUSTEDO® may cause parkinsonism
in patients with Huntington’s disease. Sedation is a common
dose-limiting adverse reaction of AUSTEDO®.
The most common adverse reactions (4% of AUSTEDO®-treated
patients and greater than placebo) in controlled clinical studies of
patients with tardive dyskinesia were nasopharyngitis and insomnia. The
most common adverse reactions (>8% of AUSTEDO®-treated
patients and greater than placebo) in a controlled clinical study of
patients with chorea associated with Huntington’s disease were
somnolence, diarrhea, dry mouth, and fatigue.
Please click here for U.S. Full Prescribing Information, including Boxed
Warning: austedo.com/hcp/pi.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva's net
revenues in 2017 were $22.4 billion. For more information, visit 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
regarding AUSTEDO®, 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. Important factors that could cause or contribute to such
differences include risks relating to:
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commercial success of AUSTEDO®;
-
our specialty medicines business, including: competition for our
specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives; our
ability to achieve expected results from investments in our product
pipeline; competition from companies with greater resources and
capabilities; and the effectiveness of our patents and other measures
to protect our intellectual property rights;
-
our substantially increased indebtedness and significantly
decreased cash on hand, which may limit our ability to incur
additional indebtedness, engage in additional transactions or make new
investments, and may result in a further downgrade of our credit
ratings; and our inability to raise debt or borrow funds in amounts or
on terms that are favorable to us;
-
our business and operations in general, including: failure to
effectively execute the restructuring plan announced in December 2017;
uncertainties related to, and failure to achieve, the potential
benefits and success of our new senior management team and
organizational structure; harm to our pipeline of future products due
to the ongoing review of our R&D programs; our ability to develop and
commercialize additional pharmaceutical products; potential additional
adverse consequences following our resolution with the U.S. government
of our FCPA investigation; compliance with sanctions and other trade
control laws; manufacturing or quality control problems, which may
damage our reputation for quality production and require costly
remediation; interruptions in our supply chain; disruptions of our or
third party information technology systems or breaches of our data
security; the failure to recruit or retain key personnel; variations
in intellectual property laws that may adversely affect our ability to
manufacture our products; challenges associated with conducting
business globally, including adverse effects of political or economic
instability, major hostilities or terrorism; significant sales to a
limited number of customers in our U.S. market; our ability to
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; and our
prospects and opportunities for growth if we sell assets;
-
compliance, regulatory and litigation matters, including: costs and
delays resulting from the extensive governmental regulation to which
we are subject; the effects of reforms in healthcare regulation and
reductions in pharmaceutical pricing, reimbursement and coverage;
governmental investigations into sales and marketing practices;
potential liability for patent infringement; product liability claims;
increased government scrutiny of our patent settlement agreements;
failure to comply with complex Medicare and Medicaid reporting and
payment obligations; and environmental risks;
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other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential significant
increases in tax liabilities; and the effect on our overall effective
tax rate of the termination or expiration of governmental programs or
tax benefits, or of a change in our business;
and other factors discussed in our Annual Report on Form 10-K for the
year ended December 31, 2017, including in the section captioned “Risk
Factors,” and in our other filings with the U.S. Securities and Exchange
Commission, which are available at www.sec.gov
and www.tevapharm.com.
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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"Tardive dyskinesia". rarediseases.info.nih.gov.
June 1, 2017. Archived from the original on June 18, 2017. Retrieved
June 10, 2017.
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Vijayakumar, D; Jankovic, J (May 2016). "Drug-Induced Dyskinesia, Part
2: Treatment of Tardive Dyskinesia". Drugs. 76 (7):
779–87. doi:10.1007/s40265-016-0568-1. PMID 27091214
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Cloud LJ, Zutshi D, Factor SA. Tardive dyskinesia: therapeutic options
for an increasingly common disorder. Neurotherapeutics.
2014;11(1):166-176.
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Tardive Dyskinesia. MHA website. http://www.mentalhealthamerica.net/tardive-dyskinesia.
Accessed June 20, 2017.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180502005176/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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or
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