Teva Announces FDA Acceptance for Review of NDA for its Investigational Twice-Daily Hydrocodone Bitartrate Extended-Release T...
25 Février 2015 - 2:00PM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) announced
today that the U.S. Food and Drug Administration (FDA) has accepted
for review the New Drug Application (NDA) for the company’s
hydrocodone bitartrate extended-release (ER) tablets formulated
with Teva’s proprietary abuse deterrence technology (CEP-33237).
CEP-33237 is an investigational, 12-hour, acetaminophen-free,
formulation of extended-release hydrocodone 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.
"Teva is committed to developing innovative approaches to
helping advance responsible pain management and is pleased the FDA
is moving forward in its consideration of CEP-33237,” said Michael
Hayden, MD, PhD, President of Global R&D and Chief Scientific
Officer at Teva. "With positive results from Human Abuse Liability
studies in the two most common routes of hydrocodone abuse,
CEP-33237 with potential abuse deterrence properties, represents a
positive step towards responsible pain management.”
The NDA filing is supported by a clinical program that evaluated
the safety and efficacy of CEP-33237, as well as the abuse
potential of CEP-33237 via the oral and intranasal routes of abuse
in Human Abuse Liability (HAL) studies:
- Results from the Phase III clinical
program for CEP-33237 showed significant improvement in the
treatment of patients’ chronic low back pain as measured by both
weekly average Worst Pain Intensity (WPI) and weekly Average Pain
Intensity (API) scores.
- In the oral HAL study in nondependent,
recreational opioid users, abuse potential was significantly lower
for finely crushed CEP-33237 than for immediate-release (IR)
hydrocodone powder based on peak at-the-moment drug liking. Overall
drug liking was also significantly lower for finely crushed
CEP-33237 compared to IR hydrocodone.
- The intranasal HAL study found that in
nondependent, recreational opioid users, abuse potential for finely
milled intranasal CEP-33237 was significantly lower based on peak
at-the-moment drug liking than for intranasal IR hydrocodone powder
and finely milled intranasal Zohydro® ER (hydrocodone bitartrate)
extended-release capsules [C-II]* as commercially available at the
time the study was conducted. Overall drug liking was also
significantly lower for finely crushed CEP-33237 compared to IR
hydrocodone and Zohydro® ER.
- CEP-33237 demonstrated a safety profile
in the Phase III study that is consistent with the known safety
profile of hydrocodone and other opioid analgesic therapies.
Adverse events reported in five percent or more of
hydrocodone-treated patients during either the titration or
double-blind treatment periods included: nausea, constipation,
vomiting, headache, somnolence and dizziness.
“The impact of living with chronic pain can be devastating,
affecting many aspects of daily life,” said Richard Malamut, MD,
Vice President of Global Clinical Development and Therapeutic Area
Head of Pain at Teva. “If approved, CEP-33237 will provide an
important treatment option for people living with chronic pain and
healthcare professionals who care for them.”
*Zohydro® ER is a registered trademark of Zogenix, Inc.
About Chronic Pain
Chronic pain is persistent pain that is not amenable to
treatments based upon specific remedies or to the routine methods
of pain control. An Institute of Medicine (IOM) report estimates
that chronic pain affects millions of American adults, including
people who reported having “severe pain,” “moderate pain,” “joint
pain,” “arthritis,” or functional limitation.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,000
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 2014 amounted to $20.3
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 innovative
products, especially Copaxone® (including competition from
orally-administered alternatives, as well as from potential
purported generic equivalents) and our ability to migrate users to
our new 40 mg/mL version; the possibility of material fines,
penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent
and during the timeframe intended by our cost reduction program;
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; 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 generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; 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, 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; and other factors that are discussed in our
Annual Report on Form 20-F for the year ended December 31, 2014 and
in our other filings with the U.S. Securities and Exchange
Commission. 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 statement, whether as a result of new
information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.IR:Kevin C.
Mannix, 215-591-8912United StatesorRan Meir,
215-591-3033United StatesorTomer Amitai, 972 (3)
926-7656IsraelorPR:Iris Beck Codner, 972 (3)
926-7687IsraelorDenise Bradley, 215-591-8974United
StatesorNancy Leone, 215-284-0213United States
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024