ST. LOUIS, Feb 10, 2011 (BUSINESS WIRE) --
Covidien (NYSE: COV), a leading global provider of healthcare products,
today announced that Mallinckrodt Inc., a Covidien company, has received
U.S. Food and Drug Administration (FDA) approval of its Abbreviated New
Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch.
Covidien is the largest supplier of controlled pain medications in the
United States based on number of prescriptions.
Covidien's FTS is a generic alternative to the branded DURAGESIC(R)
patch. FTS, a Class II controlled substance, is an opioid analgesicindicated
in opioid-tolerant patients for management of persistent, moderate to
severe chronic pain that requires continuous, around-the-clock opioid
administration for an extended period of time, and cannot be managed by
other means such as non-steroidal analgesics, opioid combination
products, or immediate-release opioids.
"Pain is one of the most common reasons patients consult a physician,
yet it is often inadequately treated," said Herbert Neuman, M.D., Chief
Medical Officer, Pharmaceuticals, Covidien. "We are pleased our FTS
product has been granted FDA approval, allowing us to introduce this
treatment option for healthcare providers to better meet patients'
Covidien expects to launch FTS in the U.S. in 25mcg/hr, 50mcg/hr,
75mcg/hr and 100mcg/hr strengths in the current quarter. The launch will
be accompanied by an extensive risk management plan to help ensure the
appropriate and safe use of this medication in accordance with both FDA
guidance and Covidien's strong focus on patient safety. This plan is
designed to minimize abuse and overdose, and includes patient and
physician education material, a medication guide, and other tools to
ensure patients who receive FTS understand the risks, appropriate use,
storage, application and disposal of FTS.
"Covidien continues to build on its extensive pain treatment experience
by focusing on providing patients with a variety of medications to make
pain more manageable," said Matthew Harbaugh, Chief Financial Officer
and Interim President, Pharmaceuticals, Covidien.
IMPORTANT RISK INFORMATION
FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
Fentanyl transdermal system contains a high concentration of a potent
Schedule II opioid agonist, fentanyl. Schedule II opioid substances
which include fentanyl, hydromorphone, methadone, morphine, oxycodone,
and oxymorphone have the highest potential for abuse and associated risk
of fatal overdose due to respiratory depression. Fentanyl can be abused
and is subject to criminal diversion. The high content of fentanyl in
the patches (fentanyl transdermal system) may be a particular target for
abuse and diversion.
Fentanyl transdermal system is indicated for management of persistent,
moderate to severe chronic pain that:
- requires continuous, around-the-clock opioid administration for an
extended period of time, and
- cannot be managed by other means such as non-steroidal analgesics,
opioid combination products, or immediate-release opioids
Fentanyl transdermal system should ONLY be used in patients who are
already receiving opioid therapy, who have demonstrated opioid
tolerance, and who require a total daily dose at least equivalent to
fentanyl transdermal system 25 mcg/hr. Patients who are considered
opioid-tolerant are those who have been taking, for a week or longer, at
least 60 mg of morphine daily, or at least 30 mg of oral oxycodone
daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic
dose of another opioid.
Because serious or life-threatening
hypoventilation could occur, fentanyl transdermal system is
- in patients who are not opioid-tolerant
- in the management of acute pain or in patients who require opioid
analgesia for a short period of time
- in the management of post-operative pain, including use after
out-patient or day surgeries (e.g., tonsillectomies)
- in the management of mild pain
- in the management of intermittent pain (e.g., use on an as needed
Since the peak fentanyl concentrations generally occur between 24 and
72 hours of treatment, prescribers should be aware that serious or
life-threatening hypoventilation may occur, even in opioid-tolerant
patients, during the initial application period.
The concomitant use of fentanyl transdermal
system with all cytochrome P450 3A4 inhibitors (such as
ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin,
nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem,
erythromycin, fluconazole, fosamprenavir, grapefruit juice, and
verapamil) may result in an increase in fentanyl plasma concentrations,
which could increase or prolong adverse drug effects and may cause
potentially fatal respiratory depression. Patients receiving fentanyl
transdermal system and any CYP3A4 inhibitor should be carefully
monitored for an extended period of time and dosage adjustments should
be made if warranted.
The safety of fentanyl transdermal system has
not been established in children under 2 years of age. Fentanyl
transdermal system should be administered to children only if they are
opioid-tolerant and 2 years of age or older.
Fentanyl transdermal system is ONLY for use in
patients who are already tolerant to opioid therapy of comparable
potency. Use in non-opioid tolerant patients may lead to fatal
respiratory depression. Overestimating the fentanyl
transdermal system dose when converting patients from another opioid
medication can result in fatal overdose with the first dose. Due to the
mean half-life of approximately 17 hours, patients who are thought to
have had a serious adverse event, including overdose, will require
monitoring and treatment for at least 24 hours.
Fentanyl transdermal system can be abused in a manner similar to
other opioid agonists, legal or illicit. This risk should be considered
when administering, prescribing, or dispensing fentanyl transdermal
system in situations where the healthcare professional is concerned
about increased risk of misuse, abuse or diversion.
Persons at increased risk for opioid abuse include those with a
personal or family history of substance abuse (including drug or alcohol
abuse or addiction) or mental illness (e.g., major depression). Patients
should be assessed for their clinical risks for opioid abuse or
addiction prior to being prescribed opioids. All patients receiving
opioids should be routinely monitored for signs of misuse, abuse and
addiction. Patients at increased risk of opioid abuse may still be
appropriately treated with modified-release opioid formulations;
however, these patients will require intensive monitoring for signs of
misuse, abuse, or addiction.
Fentanyl transdermal systems are intended for
transdermal use (on intact skin) only. Do not use a fentanyl transdermal
system if the pouch seal is broken or the patch is cut, damaged, or
changed in any way.
Avoid exposing the fentanyl transdermal system
application site and surrounding area to direct external heat sources,
such as heating pads or electric blankets, heat or tanning lamps,
saunas, hot tubs, and heated water beds, while wearing the system. Avoid
taking hot baths or sunbathing. There is a potential for
temperature-dependent increases in fentanyl released from the system
resulting in possible overdose and death. Patients wearing fentanyl
transdermal systems who develop fever or increased core body temperature
due to strenuous exertion should be monitored for opioid side effects
and the fentanyl transdermal system dose should be adjusted if necessary.
The Fentanyl Transdermal System is contraindicated in patients:
- Who have or are suspected of having paralytic ileus.
- With known hypersensitivity to Fentanyl or any components of this
In clinical trials, the 5 most common side effects >10% associated
with DURAGESIC(R) were nausea, vomiting,
sleepiness, constipation, and excessive sweating.There is a
potential for severe constipation.
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers
value through clinical leadership and excellence. Covidien manufactures,
distributes and services a diverse range of industry-leading product
lines in three segments: Medical Devices, Pharmaceuticals and Medical
Supplies. With 2010 revenue of $10.4 billion, Covidien has approximately
42,000 employees worldwide in more than 60 countries, and its products
are sold in over 140 countries. Please visit www.covidien.com
to learn more about our business.
DURAGESIC is a registered trademark of Johnson and Johnson.
Forward Looking Statements
Any statements contained in this communication that do not describe
historical facts may constitute forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995. Any
forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or Company actions to differ materially from what
is expressed or implied by these statements. The factors that could
cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to effectively
introduce and market new products or keep pace with advances in
technology, the reimbursement practices of a small number of large
public and private insurers, cost-containment efforts of customers,
purchasing groups, third-party payors and governmental organizations,
intellectual property rights disputes, complex and costly regulation,
including healthcare fraud and abuse regulations and the Foreign Corrupt
Practices Act, manufacturing or supply chain problems or disruptions,
rising commodity costs, recalls or safety alerts and negative publicity
relating to Covidien or its products, product liability losses and other
litigation liability, divestitures of some of our businesses or product
lines, our ability to execute strategic acquisitions of, investments in
or alliances with other companies and businesses, competition, risks
associated with doing business outside of the United States, foreign
currency exchange rates and environmental remediation costs. These and
other factors are identified and described in more detail in our Annual
Report on Form 10-K for the fiscal year ended September 24, 2010, and in
subsequent filings with the SEC. We disclaim any obligation to update
these forward-looking statements other than as required by law.
Lynn Phillips, 314-654-3263
Manager, Media Relations
Bruce Farmer, 508-452-4372
Vice President, Public Relations
Coleman Lannum, CFA, 508-452-4343
Vice President, Investor Relations