STAINES-UPON-THAMES, United
Kingdom, Nov. 16, 2017
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global
specialty pharmaceutical company, announced results from two
retrospective, claims-based analyses providing health economic
insights on the use of OFIRMEV® (acetaminophen)
injection – intravenous (IV) acetaminophen – versus oral
acetaminophen for managing postoperative pain in patients
undergoing bariatric surgery or appendectomy. The findings are
being presented today in moderated ePoster sessions at The American
Society of Regional Anesthesia and Pain Medicine (ASRA)
16th Annual Pain Medicine Meeting, held Nov. 16-18, in Lake
Buena Vista, Fla.
The intended audiences of these studies below are
population-based decision makers with knowledge and expertise in
the area of health care economic analysis and its limitations.
"We are pleased to share additional studies that can help
underscore the health economic value of IV acetaminophen in the
management of acute pain in the surgical setting," said
Tunde Otulana, MD, Chief Medical
Officer at Mallinckrodt. "The analyses demonstrate that
the use of IV acetaminophen was associated with decreased hospital
stays and related costs compared to oral acetaminophen, adding to
real-world evidence that can provide clinicians, pharmacists, and
hospital administrators additional health economic data."
Reduced Length of Stay and Hospitalization Costs Among
Inpatient Bariatric Patients with Postoperative Pain Management
Including Intravenous Versus Oral Acetaminophen [e-Poster
EP4224] assessed the impact of pain management including
IV acetaminophen versus oral acetaminophen on hospital length of
stay (LOS), measured by the number of days from admission to
discharge; total hospitalization costs; average daily morphine
equivalent dose or MED (a measure of total daily opioid
consumption); and potential opioid-related complications of
patients undergoing bariatric surgery starting on the day of
surgery and continuing up to the third postoperative day. This
retrospective cohort analysis of the Premier Inc. inpatient
hospital database from January 2012
to September 2015 included 39,307
patients from U.S. hospitals, with 34,645 patients
(88%) receiving IV acetaminophen.
Key highlights include:
- Compared to oral acetaminophen, use of IV acetaminophen for
post-bariatric surgical pain was associated with a significantly
shorter hospital LOS of 0.59 days (95% CI: -0.68, -0.50), a
significant decrease of $711 in
hospitalization costs (95% CI: -987, -435), and a significantly
reduced average daily MED of 10.4 mg (95% CI: -12.8, -8.0) [all
p<0.0001].
- Concerning complications that can be associated with opioid
use, patients taking IV acetaminophen were 41% less likely than
those taking oral acetaminophen to develop nausea or vomiting and
48% less likely to develop respiratory depression (both
p<0.0001).
The poster, with additional study details, is available on the
ASRA website.
Reduced Length of Stay and Hospitalization Costs Among
Inpatient Appendectomy Patients with Postoperative Pain Management
Including Intravenous Versus Oral Acetaminophen [e-Poster
EP4222] assessed the impact of pain management
including IV acetaminophen versus oral acetaminophen on hospital
LOS, total hospitalization costs, average MED, and potential
opioid-related complications of patients undergoing
appendectomy starting on the day of surgery and continuing up
to the third postoperative day. This retrospective cohort analysis
of the Premier Inc. inpatient hospital database from January 2012 to September
2015 included 35,625 patients from U.S. hospitals, with
14,236 (40%) patients receiving IV acetaminophen.
Key highlights include:
- Compared to oral acetaminophen, use of IV acetaminophen for
post-appendectomy surgical pain was associated with a significantly
shorter hospital LOS of 0.37 days (95% CI: -0.44, -0.30) and a
significant decrease of $535 in
hospitalization costs (95% CI: -729, -340) [both p<0.0001]. No
significant differences were seen between IV acetaminophen and oral
acetaminophen for average daily MED.
- Concerning complications that can be associated with opioid
use, patients taking IV acetaminophen were 15% less likely than
those receiving oral acetaminophen to develop bowel obstruction
(p<0.0001) and 16% more likely to develop respiratory depression
(P=0.031).
The poster, with additional study details, is available on the
ASRA website.
Mallinckrodt sponsored both
analyses, which were conducted in collaboration with researchers
from the University of Washington
School of Pharmacy and Brigham and Women's Hospital, a major
teaching hospital of Harvard Medical
School.
e-Poster EP4224 and e-Poster EP4222 Limitations
- The medication use data in the Premier database reflects the
amount and dose charged rather than what was administered. However,
systematic differences in billing of other pain medications between
patients who did or did not receive IV acetaminophen is not
suspected.
- The population of patients seen in Premier hospitals is not
randomly sampled. Therefore, these results may not be generalizable
outside of Premier hospitals.
ABOUT OFIRMEV (Acetaminophen) Injection
OFIRMEV is the first and only IV formulation of acetaminophen to be
approved and currently marketed in the United States. The
U.S. Food and Drug Administration approved OFIRMEV
in November 2010. OFIRMEV is available to hospitals and
outpatient and ambulatory surgical centers across the U.S.
INDICATIONS AND USAGE
OFIRMEV®
(acetaminophen) injection is indicated for the management of mild
to moderate pain in adult and pediatric patients 2 years and older,
the management of moderate to severe pain with adjunctive opioid
analgesics in adult and pediatric patients 2 years and older, and
the reduction of fever in adult and pediatric patients.
IMPORTANT SAFETY INFORMATION
WARNING:
RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
|
|
Take care when
prescribing, preparing, and administering OFIRMEV Injection to
avoid dosing errors which could result in accidental overdose and
death. In particular, be careful to ensure that:
|
|
• the dose in milligrams (mg) and milliliters (mL) is not
confused;
|
• the dosing is based on weight for patients under 50
kg;
|
• infusion pumps are properly programmed; and
|
•
the total daily dose of acetaminophen from all sources does
not exceed maximum daily limits.
|
|
OFIRMEV 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 recommended maximum
daily limits, and often involve more than one
acetaminophen-containing product.
|
Please see additional Important Safety Information, including
Boxed Warning, in the Full Prescribing Information, which can
also be found at OFIRMEV.com.
CONTRAINDICATIONS
- Acetaminophen is contraindicated in patients with
-
- known hypersensitivity to acetaminophen or to any of the
excipients in the intravenous formulation.
- severe hepatic impairment or severe active liver disease.
WARNINGS AND PRECAUTIONS
- Administration of acetaminophen in doses higher than
recommended may result in hepatic injury, including the risk of
liver failure and death. Do not exceed the maximum recommended
daily dose of acetaminophen. The maximum recommended daily dose of
acetaminophen includes all routes of acetaminophen administration
and all acetaminophen-containing products administered, including
combination products. Dosing errors could result in accidental
overdose and death.
- Use caution when administering acetaminophen in patients with
the following conditions: hepatic impairment or active hepatic
disease, alcoholism, chronic malnutrition, severe hypovolemia, or
severe renal impairment (creatinine clearance ≤ 30 mL/min).
- 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. Discontinue OFIRMEV immediately at the first sign of skin
rash.
- Take care when prescribing, preparing, and administering
OFIRMEV Injection to avoid dosing errors, which could result in
accidental overdose and death.
- Hypersensitivity and anaphylaxis associated with the use of
acetaminophen have been reported. Clinical signs included swelling
of the face, mouth, and throat, respiratory distress, urticaria,
rash, and pruritus. Discontinue OFIRMEV immediately upon occurrence
of signs or symptoms associated with allergy or hypersensitivity.
Do not use OFIRMEV in patients with acetaminophen allergy.
- The antipyretic effects of OFIRMEV may mask fever.
ADVERSE REACTIONS
- Serious adverse reactions may include hepatic injury, serious
skin reactions, allergy, and hypersensitivity.
- The most common adverse reactions in patients treated with
OFIRMEV were nausea, vomiting, headache, and insomnia in adult
patients and nausea, vomiting, constipation, and pruritus in
pediatric patients.
For additional Important Risk Information, including complete
boxed warning, see Full Prescribing Information.
ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops,
manufactures, markets and distributes specialty pharmaceutical
products and therapies. Areas of focus include autoimmune and rare
diseases in specialty areas like neurology, rheumatology,
nephrology, pulmonology and ophthalmology; immunotherapy and
neonatal respiratory critical care therapies; and analgesics and
hemostasis products. The company's core strengths include the
acquisition and management of highly regulated raw materials and
specialized chemistry, formulation and manufacturing capabilities.
The company's Specialty Brands segment includes branded medicines
and its Specialty Generics segment includes specialty generic
drugs, active pharmaceutical ingredients and external
manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a
channel of distribution of important company information, such as
press releases, investor presentations and other financial
information. It also uses its website to expedite public access to
time-critical information regarding the company in advance of or in
lieu of distributing a press release or a filing with the U.S.
Securities and Exchange Commission (SEC) disclosing the same
information. Therefore, investors should look to the Investor
Relations page of the website for important and time-critical
information. Visitors to the website can also register to receive
automatic e-mail and other notifications alerting them when new
information is made available on the Investor Relations page of the
website.
Mallinckrodt, the "M" brand mark and
the Mallinckrodt Pharmaceuticals logo are trademarks of a
Mallinckrodt company. Other brands are
trademarks of a Mallinckrodt company or
their respective owners. ©2017 Mallinckrodt. [US PRC/FIV/1117/0089] 11/17.
CONTACTS
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
View original content with
multimedia:http://www.prnewswire.com/news-releases/mallinckrodt-plc-presents-health-economic-data-on-ofirmev-acetaminophen-injection-at-asra-16th-annual-pain-medicine-meeting-300557248.html
SOURCE Mallinckrodt plc