Mallinckrodt Pharmaceuticals Presents 11 Posters with Data on Investigational Opioid, MNK-155, and XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended Release Tablets (CII) at PAINWeek 2014
LAS VEGAS--(BUSINESS WIRE)--Sep. 5, 2014--
(NYSE: MNK) presented 11 posters with data on its investigational
opioid, MNK-155, an extended-release oral formulation of hydrocodone and
acetaminophen, and recently FDA-approved XARTEMIS XR (oxycodone
hydrochloride and acetaminophen) Extended-Release Tablets (CII), at
PAINWeek, September 2-6 in Las Vegas, Nevada. The studies examined the
compound’s efficacy, safety, abuse-related characteristics and
release/delivery profiles with immediate- and extended-release
MNK-155 is an investigational extended-release oral formulation of
hydrocodone and acetaminophen being studied for the management of
moderate to moderately severe acute pain where the use of an opioid
analgesic is appropriate. XARTEMIS XR is the first and only immediate-
and extended-release oral combination of two clinically proven pain
medications - oxycodone and acetaminophen, and is indicated for the
management of acute pain severe enough to require opioid treatment and
in patients for whom alternative treatment options (e.g., non-opioid
analgesics) are ineffective, not tolerated or would otherwise be
For more information about Mallinckrodt’s presence at PAINWeek, contact
Mallinckrodt Medical Information at 1.800.788.7898 or by email.
“The data presented at PAINWeek demonstrate our continued commitment to
research in the acute pain arena based on the breadth and depth of
Mallinckrodt’s research,” said Mario Saltarelli, MD, PhD. “We plan to
continue innovating and making great strides in this category to better
serve our patients and encourage responsible use of our medications by
the people who need them.”
If you would like more information about PAINWeek, please click here.
XARTEMIS™ XR (OXYCODONE HCL AND
ACETAMINOPHEN) EXTENDED-RELEASE TABLETS, FOR ORAL USE, CII
INDICATIONS AND USAGE
XARTEMIS™ XR (oxycodone HCl and acetaminophen)
Extended-Release Tablets (CII) is indicated for the management of acute
pain severe enough to require opioid treatment and for which alternative
treatment options are inadequate. Because of the risks of addiction,
abuse, misuse, overdose, and death with opioids, even at recommended
doses, reserve XARTEMIS XR for use in patients for whom alternative
treatment options (e.g., non-opioid analgesics) are ineffective, not
tolerated or would be otherwise inadequate.
IMPORTANT RISK INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME;
Addiction, Abuse, and Misuse
XARTEMIS XR 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 XARTEMIS XR, and monitor
all patients regularly for the development of these behaviors or
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of XARTEMIS XR. Monitor for respiratory depression, especially
during initiation of XARTEMIS XR or following a dose increase. Instruct
patients to swallow XARTEMIS XR tablets whole; crushing, chewing, or
dissolving XARTEMIS XR can cause rapid release and absorption of a
potentially fatal dose of oxycodone.
Accidental ingestion of XARTEMIS XR, especially in children, can
result in a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of XARTEMIS XR during pregnancy can result in neonatal
opioid withdrawal syndrome, which may be life-threatening if not
recognized 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
XARTEMIS XR contains acetaminophen. Acetaminophen has been associated
with cases of acute liver failure, at times resulting in liver
transplant and death. Most of the cases of liver injury are associated
with the use of acetaminophen at doses that exceed the maximum daily
limit, and often involve more than one acetaminophen-containing product.
XARTEMIS XR is contraindicated in patients with:
known hypersensitivity to oxycodone, acetaminophen, or any other
component of this product.
significant respiratory depression.
acute or severe bronchial asthma or hypercarbia.
known or suspected paralytic ileus.
WARNINGS AND PRECAUTIONS
XARTEMIS XR contains oxycodone, a Schedule II controlled substance. As
an opioid, XARTEMIS XR exposes users to the risks of addiction, abuse,
and misuse. Abuse or misuse of XARTEMIS XR by crushing, chewing,
snorting, or injecting the dissolved product will result in the
uncontrolled delivery of the oxycodone and can result in overdose and
death. With intravenous abuse, the inactive ingredients in XARTEMIS XR
can result in death, local tissue necrosis, infection, pulmonary
granulomas, and increased risk of endocarditis and valvular heart
injury. Parenteral drug abuse is commonly associated with transmission
of infectious diseases such as hepatitis and HIV.
Serious, life-threatening, or fatal respiratory depression has been
reported with the use of opioids, even when used as recommended. While
serious, life-threatening, or fatal respiratory depression can occur
at any time during the use of XARTEMIS XR, the risk is greatest during
the initiation of therapy or following a dose increase.
Life-threatening respiratory depression is more likely to occur in
elderly, cachectic, or debilitated patients as they may have altered
pharmacokinetics or altered clearance compared to younger, healthier
patients. In patients with significant chronic obstructive pulmonary
disease or cor pulmonale, and patients having a substantially
decreased respiratory reserve, hypoxia, hypercapnia, or preexisting
respiratory depression, XARTEMIS XR may decrease respiratory drive to
the point of apnea.
Hypotension, profound sedation, coma, respiratory depression, and
death may result if XARTEMIS XR is used concomitantly with alcohol or
other central nervous system (CNS) depressants.
The risk of acute liver failure is higher in individuals with
underlying liver disease and in individuals who ingest alcohol while
Rarely, acetaminophen may cause serious skin reactions such as acute
generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome
(SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
The respiratory depressant effects of narcotics and their capacity to
elevate cerebrospinal fluid pressure may be markedly exaggerated in
the presence of head injury, other intracranial lesions, or a
pre-existing increase in intracranial pressure.
Oxycodone may cause severe hypotension particularly in individuals
whose ability to maintain blood pressure has been compromised by a
depleted blood volume, or after concurrent administration with drugs
which compromise vasomotor tone such as phenothiazines.
Due to the potential for acetaminophen hepatotoxicity at doses higher
than 4000 milligrams/day, XARTEMIS XR should not be used concomitantly
with other acetaminophen- containing products.
Hypersensitivity and anaphylaxis associated with use of acetaminophen
have been reported. Clinical signs included swelling of the face,
mouth, and throat, respiratory distress, urticaria, rash, pruritus,
Due to characteristics of the formulation that cause the tablets to
swell and become sticky when wet, consider use of an alternative
analgesic in patients who have difficulty swallowing and patients at
risk for underlying GI disorders resulting in a small gastrointestinal
lumen. Instruct patients not to pre-soak, lick or otherwise wet
XARTEMIS XR tablets prior to placing in the mouth, and to take one
tablet at a time with enough water to ensure complete swallowing
immediately after placing in mouth.
Opioids diminish propulsive peristaltic waves in the gastrointestinal
tract and decrease bowel motility. Oxycodone may cause spasm of the
Sphincter of Oddi and should be used with caution in patients with
biliary tract disease, including acute pancreatitis.
Since the CYP3A4 isoenzyme plays a major role in the metabolism of
XARTEMIS XR, drugs that alter CYP3A4 activity may cause changes in
clearance of oxycodone which could lead to changes in oxycodone plasma
XARTEMIS XR may impair the mental and/or physical abilities required
for the performance of potentially hazardous tasks such as driving a
car or operating machinery. The patient using this drug should be
Serious adverse events may include respiratory depression and
Common adverse events include nausea, dizziness, headache, vomiting,
constipation and somnolence.
USE IN SPECIFIC POPULATIONS
Pregnancy: Opioids cross the placenta and may produce respiratory
depression and psycho-physiologic effects in neonates. Prolonged use
of XARTEMIS XR during pregnancy can result in withdrawal signs in the
neonate, which can be life threatening.
Breast feeding: Oxycodone is present in human milk and may result in
accumulation and toxicities such as sedation and respiratory
depression in some infants. Acetaminophen is present in human milk in
Pediatrics: Safety and effectiveness in pediatric patients under the
age of 18 years have not been established.
Prescribing Information for additional Important Risk
Information including boxed warning.
About XARTEMIS™ XR
XARTEMIS XR is an extended-release oral formulation of oxycodone
hydrochloride and acetaminophen with immediate-release and
extended-release components. It is not interchangeable with other
oxycodone/acetaminophen products because of differing pharmacokinetic
profiles that affect the frequency of administration. XARTEMIS XR is a
schedule II controlled substance.
Mallinckrodt is a global specialty pharmaceutical and medical imaging
business that develops, manufactures, markets and distributes specialty
pharmaceutical products and medical imaging agents. Areas of focus
include analgesics and central nervous system drugs for prescribing by
office- and hospital-based physicians, and autoimmune and rare disease
specialty areas like neurology, rheumatology, nephrology and
pulmonology. The company's core strengths include the acquisition and
management of highly regulated raw materials; deep regulatory expertise;
and specialized chemistry, formulation and manufacturing capabilities.
The company's Specialty Pharmaceuticals segment includes branded and
specialty generic drugs and active pharmaceutical ingredients, and the
Global Medical Imaging segment includes contrast media and nuclear
imaging agents. Mallinckrodt has more than 5,500 employees worldwide and
a commercial presence in roughly 65 countries. The company's fiscal 2013
revenue totaled $2.2 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Lynn Phillips, 314-654-3263
Manager, Media Relations
Senior Vice President, Communications
Vice President, Investor Relations