Teva to Present AUSTEDO® (deutetrabenazine) Tablets Data at the American Psychiatric Association 2018 Annual Meeting
2018年5月2日 - 9:00PM
ビジネスワイヤ(英語)
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
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:
- [P6.137] Measuring the Health Status
Burden of Tardive Dyskinesia (Poster Session 6, May 7, 2018,
2:00-4:00 p.m. ET)
- [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)
- [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)
- [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)
- [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)
- [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:
- 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;
- 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.
- "Tardive dyskinesia".
rarediseases.info.nih.gov. June 1, 2017. Archived from the original
on June 18, 2017. Retrieved June 10, 2017.
- 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
- Cloud LJ, Zutshi D, Factor SA. Tardive
dyskinesia: therapeutic options for an increasingly common
disorder. Neurotherapeutics. 2014;11(1):166-176.
- Tardive Dyskinesia. MHA website.
http://www.mentalhealthamerica.net/tardive-dyskinesia. Accessed
June 20, 2017.
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version on businesswire.com: https://www.businesswire.com/news/home/20180502005176/en/
Teva Pharmaceutical Industries Ltd.IR ContactsUnited
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926 7656orPR
ContactsUnited StatesDoris Saltkill,
816-391-8881orIsraelYonatan Beker, 972 (54) 888 5898
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