New extended-release formulation available for around-the-clock pain
ST. LOUIS, Apr 26, 2010 (BUSINESS WIRE) --Covidien (NYSE: COV), a leading global provider of healthcare products,
today introduced EXALGO(TM) (hydromorphone HCI) Extended-Release Tablets,
(CII), the only extended-release hydromorphone treatment available in
the United States. This proven therapy, combined with an innovative
delivery system, provides opioid-tolerant patients suffering from
moderate-to-severe chronic pain relief for 24 hours per dose.
Approved by the U.S. Food and Drug Administration (FDA) on March 1,
2010, EXALGO tablets provide a well-known therapy in hydromorphone HCl -
used in the treatment of chronic pain for more than 80 years. The
indication for EXALGO is once-daily administration 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. EXALGO is available in 8 mg, 12 mg and 16 mg tablets.
"Chronic pain patients experience pain so severe it can often be
crippling," said noted pain treatment expert, Dr. Lynn Webster, Medical
Director of Lifetree Clinical Research and Pain Clinic in Salt Lake
City, Utah. "This pain can make it almost impossible for patients to
hold a job, or to do simple activities, such as going to the grocery
store or taking their child to soccer practice. Extended-release
formulations like EXALGO can help make daily pain more manageable by
avoiding the peaks and troughs of pain that can occur with short-acting
Currently there is an unmet need for longer-lasting treatments to manage
chronic pain. In the 2006 American Pain Foundation's Voices of
Chronic PainSurvey, only 23 percent of chronic pain patients
reported their medications were "very effective."1
Historically, patients who suffered from chronic pain may have been
prescribed short-acting opioids or some other extended-release opioids,
which would have caused them to take multiple doses of their pain
medication over the course of one day.
"As the largest supplier of generic controlled pain medications in the
United States, based on number of prescriptions, Covidien is focused on
providing patients with access to advanced medications that expand the
limits of pain therapy by combining proven drugs with innovative
delivery systems," said Timothy R. Wright, President, Pharmaceuticals,
Covidien. "With the launch of EXALGO tablets, opioid-tolerant chronic
pain patients will be given the option to take one dose each day that
provides 24 hours of relief and keeps pain waiting. This is a
breakthrough for pain management."
EXALGO utilizes the OROS(R) Push-Pull(TM) osmotic delivery system
designed to release the opioid at a controlled rate. By providing a
steady release of hydromorphone throughout the day, the drug is
formulated to help minimize the peaks and troughs that are sometimes
experienced by chronic pain patients who rely on products that are dosed
at more frequent intervals to deliver pain relief.
With the addition of extended-release opioids to the pain treatment
landscape, physicians have another tool to help patients manage what is
often debilitating moderate-to-severe chronic pain.
The launch of EXALGO tablets includes a comprehensive Risk Evaluation
and Mitigation Strategy (REMS) program that is designed to assure the
safe use of EXALGO. The REMS program for EXALGO includes a medication
guide and a robust set of educational programs and materials. Covidien's
focused effort to help ensure that prescribers, pharmacists and patients
have the needed information regarding appropriate prescribing,
dispensing and use of EXALGO tablets will be an important piece of the
EXALGO REMS program. Under the program, healthcare provider education is
required as an important element to assure safe use, with a focus on
appropriate patient selection and dosing. There is no restricted
distribution network for EXALGO, and no requirement for physicians,
pharmacists or patients to enroll in a registry in order to access the
As part of Covidien's ongoing commitment to be a responsible advocate
for patients, the Company also has developed a broad range of voluntary
safe-use tools for EXALGO that will be provided to healthcare
professionals, pharmacists, patients and caregivers. These materials
include a patient/prescriber medication agreement, patient counseling
guide and additional safe-use tools. All materials will be continually
reviewed and updated based on feedback from patients and prescribers.
For more information about EXALGO, log on to www.keeppainwaiting.com.
IMPORTANT RISK INFORMATION
WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT
SELECTION AND LIMITATIONS OF USE
Potential for Abuse
EXALGO contains hydromorphone, an opioid agonist and a Schedule
II controlled substance with an abuse liability similar to other
opioid analgesics. EXALGO can be abused in a manner similar to
other opioid agonists, legal or illicit. These risks should be
considered when administering, prescribing or dispensing EXALGO in
situations where the healthcare professional is concerned about
increased risk of misuse, abuse or diversion. Schedule II opioid
substances, which include hydromorphone, morphine, oxycodone,
fentanyl, oxymorphone and methadone, have the highest potential
for abuse and risk of fatal overdose due to respiratory
Proper Patient Selection
EXALGO is an extended-release formulation of hydromorphone
hydrochloride indicated for the management of moderate-to-severe
pain in opioid tolerant patients when a continuous
around-the-clock opioid analgesic is needed for an extended period
of time. Patients considered opioid tolerant are those who are
taking at least 60 mg oral morphine per day, 25 mcg transdermal
fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral
hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic
dose of another opioid, for a week or longer.
EXALGO is for use in opioid-tolerant patients only.
Fatal respiratory depression could occur in patients who are
not opioid tolerant.
Accidental consumption of EXALGO, especially in children, can
result in a fatal overdose of hydromorphone.
Limitations of Use
EXALGO is not indicated for the management of acute or
EXALGO is not intended for use as an as-needed analgesic.
EXALGO tablets are to be swallowed whole and are not to be
broken, chewed, dissolved, crushed or injected. Taking broken,
chewed, dissolved or crushed EXALGO or its contents leads to rapid
release and absorption of a potentially fatal dose of
EXALGO is also contraindicated in patients who:
need management of mild pain or pain not expected to persist
have significant impaired respiratory function including those
with acute or severe bronchial asthma or hypercarbia.
have or are suspected to have paralytic ileus
have narrowed or obstructed gastrointestinal (GI) tract including
those resulting from previous surgery or "blind loops" in the GI
have known hypersensitivity to any components including
hydromorphone hydrochloride and sulfites
Avoid concurrent use of alcohol and EXALGO. Concurrent use of EXALGO
with central nervous system (CNS) depressants, including alcohol,
increases risk of respiratory depression, hypotension, and profound
sedation, potentially resulting in coma or death. EXALGO may impair
the ability to drive a car or operate machinery.
Not intended for use in patients who have received monoamine oxidase
(MAO) inhibitors within 14 days of starting EXALGO.
Use with caution and in reduced doses in older or debilitated
patients, as well as patients with renal or hepatic insufficiency,
Addison's disease, delirium tremens, myxedema or hypothyroidism,
prosthetic hypertrophy or urethral stricture, toxic psychosis. May
aggravate convulsions in patients with convulsive disorders; may
induce or aggravate seizures in some clinical settings. Consider use
of an alternate analgesic in patients with severe renal impairment.
Respiratory depression, which occurs more frequently in elderly or
debilitated patients, is the chief hazard with EXALGO.
Most common adverse events (>10%) seen in clinical studies (N=2474)
were: constipation (31%), nausea (28%), vomiting, somnolence,
headache, asthenia and dizziness. Serious adverse events could also
include head injury, hypotensive effects, GI effects, cardiac arrest
from overdose and precipitation of withdrawal.
Use EXALGO with extreme caution in patients susceptible to
intracranial effects of CO2 retention.
Do not abruptly discontinue EXALGO.
See Full Prescribing Information for additional Important Risk
Information at http://www.exalgo.com/media/pdf/EXALGO_FullPrescribingInformation.pdf
EXALGO is a trademark of Mallinckrodt Inc.
OROS and Push-Pull are trademarks of ALZA Corporation.
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 2009 revenue of $10.7 billion, Covidien has 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.
1 Voices of Chronic Pain Survey, The American Pain
Foundation. May 2006.
JoAnna Schooler, 314-654-3543
Stephen Littlejohn, 314-654-6595
Vice President, Communications
Coleman Lannum, CFA, 508-452-4343
Brian Nameth, 508-452-4363