HAZELWOOD, Mo.--(BUSINESS WIRE)--Aug. 23, 2012--
Mallinckrodt, the Pharmaceuticals business of Covidien
(NYSE: COV), today announced that it has entered into an agreement with
Xanodyne Pharmaceuticals to purchase Roxicodone® (oxycodone
hydrochloride tablets USP) in 5, 15 and 30 mg dosage strengths.
Roxicodone, currently marketed in the United States, is an immediate
release formulation of oxycodone indicated for the management of
moderate to severe pain where the use of an opioid analgesic is
appropriate. With this agreement, Mallinckrodt acquires all rights to
the Roxicodone New Drug Application (NDA). No financial details were
"We are excited about this agreement as it complements our existing
portfolio of opioids and leverages our pain management expertise,” said
Mark Trudeau, President, Pharmaceuticals. “More importantly, we are
committed to safe and effective use of all of our products along with
ensuring access for all patients in need of pain treatment.”
Mallinckrodt is the largest U.S. supplier of opioid pain medications and
among the top 10 generic pharmaceuticals manufacturers in the U.S.,
based on prescriptions. Its branded portfolio includes EXALGO®
(hydromorphone HCl) Extended-Release Tablets (CII) and PENNSAID®
(diclofenac sodium topical solution) 1.5% w/w. Mallinckrodt is also one
of the world’s leading producers of bulk acetaminophen.
Covidien announced last December that the Company planned to spin off
Mallinckrodt into a stand-alone company, a process that is expected to
be completed in mid-2013.
IMPORTANT RISK INFORMATION
Roxicodone tablets are contraindicated in patients with known
hypersensitivity to oxycodone, or in any situation where opioids are
contraindicated. This includes patients with significant respiratory
depression (in unmonitored settings or the absence of resuscitative
equipment) and patients with acute or severe bronchial asthma or
hypercarbia. Oxycodone hydrochloride tablets are contraindicated in any
patient who has or is suspected of having paralytic ileus.
Serious adverse reactions that may be associated with Roxicodone tablets
therapy include: respiratory depression, respiratory arrest, circulatory
depression, cardiac arrest, hypotension, and/or shock. Common adverse
events that may be associated with Roxicodone tablets therapy include:
nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness,
asthenia, and somnolence.
EXALGO® (hydromorphone HCI) Extended-Release Tablets (CII) is
indicated for the management of moderate to severe pain in opioid
tolerant patients requiring continuous, around-the-clock opioid
analgesia for an extended period of time.
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY
DEPRESSION, and ACCIDENTAL EXPOSURE
EXALGO contains hydromorphone, an opioid agonist and a Schedule
II controlled substance with an abuse liability similar to other
opioid agonists, legal or illicit. Assess each patient’s risk for
opioid abuse or addiction prior to prescribing EXALGO. The risk
for opioid abuse is increased in patients with a personal or
family history of substance abuse (including drug or alcohol abuse
or addiction) or mental illness (e.g., major depressive disorder).
Routinely monitor all patients receiving EXALGO for signs of
misuse, abuse, and addiction during treatment.
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with
use of EXALGO, even when the drug has been used as recommended and
not misused or abused. EXALGO is for use in opioid tolerant
patients only. Proper dosing and titration are essential and
EXALGO should be prescribed only by healthcare professionals who
are knowledgeable in the use of potent opioids for the management
of chronic pain. Monitor for respiratory depression, especially
during initiation of EXALGO or following a dose increase.
Crushing, dissolving, or chewing the tablet can cause rapid
release and absorption of a potentially fatal dose of
Accidental ingestion of EXALGO, especially in children, can
result in a fatal overdose of hydromorphone.
EXALGO is contraindicated in:
Opioid non-tolerant patients. Fatal respiratory depression could
occur in patients who are not opioid tolerant.
Patients with significant respiratory depression
Patients with acute or severe bronchial asthma in an unmonitored
setting or in the absence of resuscitative equipment
Patients with known or suspected paralytic ileus
Patients who have had surgical procedures and/or underlying
disease resulting in narrowing of the gastrointestinal tract, or
have “blind loops” of the gastrointestinal tract or
Patients with hypersensitivity (e.g., anaphylaxis) to
hydromorphone or sulfite-containing medications
Serious adverse events could also include hypotensive effects, GI
effects, cardiac arrest from overdose and precipitation of withdrawal.
Most common adverse events (>10%) seen in clinical studies (N=2474)
were: constipation (31%), nausea (28%), vomiting, somnolence,
headache, asthenia and dizziness.
PENNSAID is a nonsteroidal anti-inflammatory drug (“NSAID”) indicated
for the treatment of signs and symptoms of osteoarthritis of the knee(s).
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
• Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an
increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk
may increase with duration of use. Patients with cardiovascular
disease or risk factors for cardiovascular disease may be at
• PENNSAID is contraindicated in the perioperative setting of
coronary artery bypass graft (CABG) surgery.
• NSAIDs cause an increased risk of serious gastrointestinal
adverse events including bleeding, ulceration, and perforation of
the stomach or intestines, which can be fatal. These events can
occur at any time during use and without warning symptoms. Elderly
patients are at greater risk for serious gastrointestinal events.
PENNSAID is also contraindicated in patients:
With known hypersensitivity to diclofenac sodium or any other
component of PENNSAID.
Who have experienced asthma, urticaria, or allergic-type reactions
after taking aspirin or other NSAIDs. Severe, rarely fatal,
anaphylactic-like reactions have been reported in these patients.
Anaphylactoid reactions may occur in patients without prior exposure
to PENNSAID. NSAIDs can cause serious skin adverse events such as
exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic
epidermal necrosis (TEN), which can be fatal.
The most common treatment-related adverse events in patients
receiving PENNSAID were application site skin reactions including dry
skin (32%), contact dermatitis characterized by skin erythema and
induration (9%), contact dermatitis with vesicles (2%) and pruritus
(4%). In a long term safety study, contact dermatitis occurred in 13%
and contact dermatitis with vesicles in 10% of patients, generally
within the first 6 months of exposure, leading to a withdrawal rate for
an application site event of 14%. Other common adverse events greater
than placebo include: dyspepsia (8%), abdominal pain (6%), flatulence
(4%), diarrhea (4%) and nausea (4%).
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 2011 revenue of $11.6 billion, Covidien has 43,000
employees worldwide in more than 65 countries, and its products are sold
in over 140 countries. Mallinckrodt, the Pharmaceuticals business of
Covidien, manufactures active pharmaceutical ingredients, including bulk
acetaminophen, opioid pain medications, nuclear and contrast media
diagnostic agents. Sales in 2011 were $2.0 billion. Please visit www.covidien.com
to learn more about our business.
EXALGO is a registered trademark of Mallinckrodt LLC. PENNSAID is a
registered trademark of Nuvo Research Inc. Roxicodone is a registered
trademark of Xanodyne Pharmaceuticals, Inc.
Lynn Phillips, 314-654-3263
Manager, Media Relations
Vice President Communications
Lannum, CFA, 508-452-4343