VANTRELA ER label describes the product’s
abuse-deterrent properties against abuse in the three most common
routes—oral, intranasal and intravenous
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the U.S. Food and Drug Administration (FDA) approved
VANTRELATM ER (hydrocodone bitartrate) extended-release tablets
[CII] formulated with Teva’s proprietary abuse deterrence
technology. VANTRELA ER is indicated for the management of pain
severe enough to require daily, around-the-clock, long-term opioid
treatment and for which alternative treatment options are
inadequate. The product’s approval is supported by a clinical
program that evaluated the safety and efficacy of VANTRELA ER, as
well as its abuse potential in laboratory-based in vitro
manipulation and extraction studies, pharmacokinetic studies, and
clinical abuse potential (CAP) studies.
“Teva understands the risk of prescription drug abuse is a
challenge healthcare professionals face when treating millions of
Americans affected by chronic pain,” said Rob Koremans, MD,
President and CEO of Global Specialty Medicines at Teva.
“Abuse-deterrent treatments provide options for prescribers that
may help deter or mitigate abuse while still preserving access to
pain medications for the patients that need them most.”
The VANTRELA ER prescribing information (PI) describes the
product’s abuse-deterrent properties that are expected to reduce,
but not totally prevent, oral, intranasal and intravenous abuse of
the drug when the tablets are manipulated. As an opioid, VANTRELA
ER is associated with serious risks and the PI contains a Boxed
Warning that includes addiction, abuse, and misuse, which can lead
to overdose and death, as well as serious, life-threatening, or
fatal respiratory depression. Additional boxed warnings and other
important safety information can be found below and in the
prescribing information.
Michael Hayden, MD, PhD, President of Global R&D and Chief
Scientific Officer at Teva said, “While no technology can
completely eliminate abuse, Teva’s proprietary abuse deterrence
technology is an important step forward. We are committed to
furthering responsible pain management.”
Adverse reactions in ≥2% of patients in placebo-controlled
trials include nausea, constipation, headache, somnolence,
vomiting, dizziness, pruritus, fatigue, dry mouth, diarrhea,
insomnia, and anxiety.
ABOUT VANTRELA ER
VANTRELA™ ER (hydrocodone bitartrate) extended-release tablets
[CII] is an opioid agonist indicated for the management of pain
severe enough to require daily, around-the-clock, long-term opioid
treatment and for which alternative treatment options are
inadequate.
Limitation of Use
- Because of the risks of addiction,
abuse, and misuse with opioids, even at recommended doses, and
because of the greater risks of overdose and death with
extended-release opioid formulations, reserve VANTRELA ER for use
in patients for whom alternative treatment options (e.g.,
non-opioid analgesics or immediate-release opioids) are
ineffective, not tolerated, or would be otherwise inadequate to
provide sufficient management of pain.
- VANTRELA ER is not indicated as an
as-needed (prn) analgesic.
VANTRELA ER contains hydrocodone, a substance with a high
potential for abuse similar to other opioids, including fentanyl,
hydromorphone, methadone, morphine, oxycodone, oxymorphone, and
tapentadol.
Important Safety Information
VANTRELA ER exposes patients and other users to the risks of
opioid addiction, abuse, and misuse, which can lead to overdose and
death. Assess each patient’s risk prior to prescribing VANTRELA ER
and monitor all patients regularly for the development of these
behaviors and conditions.
Serious, life-threatening, or fatal respiratory depression
may occur with the use of VANTRELA ER. Monitor for respiratory
depression, especially during initiation of VANTRELA ER or
following a dose increase. Instruct patients to swallow VANTRELA ER
tablets whole; crushing, chewing or dissolving VANTRELA ER tablets
can cause rapid release and absorption of a potentially fatal dose
of hydrocodone.
Accidental ingestion of even one dose of VANTRELA ER,
especially by children, can result in a fatal overdose of
hydrocodone.
Prolonged use of VANTRELA ER during pregnancy can result in
neonatal opioid withdrawal syndrome, which may be life-threatening
if not recognized and treated, and requires management according to
protocols developed by neonatology experts. If opioid use is
required for a prolonged period in a pregnant woman, advise the
patient of the risk of neonatal opioid withdrawal syndrome and
ensure that appropriate treatment will be available.
The concomitant use of VANTRELA ER with all cytochrome P450
3A4 inhibitors may result in an increase in hydrocodone plasma
concentrations, which could increase or prolong adverse drug
effects and may cause potentially fatal respiratory depression. In
addition, discontinuation of a concomitantly used cytochrome P450
3A4 inducer may result in an increase in hydrocodone plasma
concentration. Monitor patients receiving VANTRELA ER and any
CYP3A4 inhibitor or inducer.
Concomitant use of opioids with benzodiazepines or other
central nervous system (CNS) depressants, including alcohol, may
result in profound sedation, respiratory depression, coma, and
death.
- Reserve concomitant prescribing of
VANTRELA ER and benzodiazepines or other CNS depressants for use in
patients for whom alternative treatment options are
inadequate.
- Limit dosages and durations to the
minimum required.
- Follow patients for signs and
symptoms of respiratory depression and sedation.
VANTRELA ER is contraindicated in patients with: significant
respiratory depression; acute or severe bronchial asthma in an
unmonitored setting or in the absence of resuscitative equipment;
known or suspected gastrointestinal obstruction, including
paralytic ileus; or hypersensitivity (e.g., anaphylaxis) to
hydrocodone bitartrate or any other ingredients in VANTRELA ER.
VANTRELA ER-treated patients with significant chronic
obstructive pulmonary disease or cor pulmonale, and those with a
substantially decreased respiratory reserve, hypoxia, hypercapnia,
or pre-existing respiratory depression are at increased risk of
decreased respiratory drive including apnea, even at recommended
dosages of VANTRELA ER.
Life-threatening respiratory depression is more likely to occur
in elderly, cachectic, or debilitated patients because they may
have altered pharmacokinetics or altered clearance compared to
younger, healthier patients.
Cases of adrenal insufficiency have been reported with opioid
use, more often following greater than one month of use.
VANTRELA ER may cause severe hypotension including orthostatic
hypotension and syncope in ambulatory patients. There is an added
risk to individuals whose ability to maintain blood pressure has
been compromised by a depleted blood volume or concurrent
administration of certain CNS depressants (e.g., phenothiazines or
general anesthetics). In patients with circulatory shock, VANTRELA
ER may cause vasodilation that can further reduce cardiac output
and blood pressure.
In patients who may be susceptible to the intracranial effects
of CO2 retention (e.g., those with evidence of increased
intracranial pressure as can be caused by certain brain tumors),
VANTRELA ER may reduce respiratory drive, and the resultant CO2
retention can further increase intracranial pressure. Opioids may
also obscure the clinical course in a patient with a head
injury.
The hydrocodone in VANTRELA ER may cause spasm of the sphincter
of Oddi. Opioids may cause increases in serum amylase.
The hydrocodone in VANTRELA ER may increase the frequency of
seizures in patients with seizure disorders, and may increase the
risk of seizures occurring in other clinical settings associated
with seizures.
Avoid the use of mixed agonist/antagonist (e.g., pentazocine,
nalbuphine, and butorphanol) or partial agonist (e.g.,
buprenorphine) analgesics in patients who are receiving a course of
therapy with a full opioid agonist analgesic, including VANTRELA
ER. In these patients, mixed agonist/antagonist and partial agonist
analgesics may reduce the analgesic effect and/or may precipitate
withdrawal symptoms.
VANTRELA ER may impair the mental and physical abilities needed
to perform potentially hazardous activities such as driving a car
or operating machinery.
QTc prolongation has been observed with VANTRELA ER.
Adverse reactions reported in ≥2% of patients in the
placebo-controlled trials include: nausea, constipation, headache,
somnolence, vomiting, dizziness, pruritus, fatigue, dry mouth,
diarrhea, insomnia, and anxiety.
The Full Prescribing Information, including the Boxed Warning
and Medication Guide for VANTRELA ER is available at
VANTRELAER.com.
A copy of the Prescribing Information may also be requested from
the US Medical Information Contact Center for Teva Specialty
Medicines at 888-4-TEVA-RX (888-483-8279) and
USMedInfo@tevapharm.com or Teva’s Public Relations or Investor
Relations contacts.
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 2015
were $19.7 billion. For more information,
visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to develop and commercialize
additional pharmaceutical products; competition for our specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our
ability to realize the anticipated benefits of the acquisition
of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”), and the timing of realizing such
benefits; our ability to fully and efficiently integrate Actavis
Generics and to achieve the anticipated cost savings, synergies,
business opportunities and growth prospects from the combination;
the fact that we are now dependent to a much larger extent than
previously on our generic pharmaceutical business; our ability to
develop and launch new generic products from the Actavis Generics
pipeline on the anticipated timelines; potential restrictions on
our ability to engage in additional transactions or incur
additional indebtedness as a result of the substantial amount of
debt we have incurred to finance the Actavis Generics acquisition;
the fact that we will have significantly less cash on hand than
prior to the consummation of the Actavis Generics acquisition,
which could adversely affect our ability to grow; our ability to
achieve expected results from investments in our pipeline of
specialty and other products; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the
extent to which any manufacturing or quality control problems
damage our reputation for quality production and require costly
remediation; increased government scrutiny in both the U.S.
and Europe of our patent settlement agreements; our exposure
to currency fluctuations and restrictions as well as credit risks;
the effectiveness of our patents, confidentiality agreements and
other measures to protect the intellectual property rights of our
specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability,
major hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with
internal or third-party information technology systems that
adversely affect our complex manufacturing processes; significant
disruptions of our information technology systems or breaches of
our data security; competition for our specialty pharmaceutical
businesses from companies with greater resources and capabilities;
the impact of continuing consolidation of our distributors and
customers; decreased opportunities to obtain U.S. market
exclusivity for significant new generic products; potential
liability in the U.S., Europe and other markets for sales
of generic products prior to a final resolution of outstanding
patent litigation; our potential exposure to product liability
claims that are not covered by insurance; any failure to recruit or
retain key personnel, including, in particular, former Actavis
Generics personnel who have transitioned to Teva or to attract
additional executive and managerial talent; any failures to comply
with complex Medicare and Medicaid reporting
and payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access
to the capital markets; potentially significant increases in tax
liabilities; 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; variations in patent laws that may
adversely affect our ability to manufacture our products in the
most efficient manner; environmental risks; the possibility of
additional adverse consequences arising from our recent
FCPA-related settlement with the U.S. government, including
limitations on our conduct of business in various countries,
adverse judgments in shareholder lawsuits and fines, penalties or
other sanctions imposed by government authorities in other
countries; and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31,
2015 and in our other filings with the U.S. Securities
and Exchange Commission (the SEC). 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, whether as a result of new
information, future events or otherwise.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170118005660/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7246orUnited StatesDenise Bradley,
215-591-8974orNancy Leone, 215-284-0213
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024