Health Economic Data on OFIRMEV® (Acetaminophen) Injection Presented at 28th Annual National Forum of the Institute for Healthcare Improvement

CHESTERFIELD, United Kingdom, Dec. 7, 2016 /PRNewswire/ -- Mallinckrodt Pharmaceuticals (NYSE: MNK), a leading global specialty pharmaceutical company, announced results from a retrospective, claims-based health economic analysis on use of intravenous (IV) acetaminophen versus oral acetaminophen for managing post-operative pain in patients undergoing total knee arthroplasty. The results were presented Tuesday, Dec. 6, 2016, at the 28^th Annual National Forum on Quality Improvement in Health Care of the Institute for Healthcare Improvement (IHI) in Orlando, Fla.

"Triple Aim as a Conceptual Framework for Conducting Comparative Effectiveness Research in Postoperative Pain" [Pham A, Hansen R, Böing EA, Wan GJ, Lovelace B, Miller TE] utilized IHI's Triple Aim framework[1] to assess certain outcomes resulting from different treatment strategies for postoperative pain management. Triple Aim requires simultaneous pursuit of reducing health care expenditures, improving patient experience and advancing population health. (Access the data abstract and/or poster online. Please note you will need to register on the website and then type "Mallinckrodt" into the organization search field on the right.) 

The analysis included patients undergoing total knee arthroplasty starting on the day of surgery and continuing up to the third postoperative day, and examined the impact of IV acetaminophen (OFIRMEV) versus oral acetaminophen – administered as components of a multimodal analgesia (MMA) pain management strategy – on:

• Health care expenditures measured in terms of hospital length of stay (LOS) and total hospitalization costs,
• Patient experience related to potential opioid-related complications and opioid consumption, and
• Population health measures reflecting post-hospital discharge outcomes including 30-day readmissions and discharge status to home or skilled nursing facility.

The retrospective cohort analysis of the Premier Inc. inpatient hospital database from January 2012 to September 2015 included 190,691 total knee arthroplasty surgical patients from U.S. hospitals, with 56,475 patients (30%) receiving IV acetaminophen. Subjects were included regardless of additional pain management modalities administered.

Results
The retrospective analysis showed that, compared to oral acetaminophen, use of IV acetaminophen as a component of MMA pain management was associated with:

• Health care expenditures: Shorter LOS and decreased hospitalization costs;
• Patient experience: Reduced opioid-use and opioid-related complications;
• Population health: Lower likelihood of 30-day readmissions or discharge to skilled nursing facility, and greater likelihood of home discharge.

The analysis was conducted in collaboration with researchers from the University of Washington School of Pharmacy and Duke University School of Medicine.

Health Economic Research Limitations

• The differences observed between IV and oral acetaminophen patients on outcomes (e.g., LOS, hospitalization costs, morphine equivalent dose, hospital discharge status or readmissions, bowel obstruction, nausea/vomiting, respiratory depression) could be explained by unmeasured confounders. Investigators attempted to statistically adjust for these differences in accounting for potentially confounding variables, but unmeasured factors might still play a role in the associations reported.
• 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 although the database represents 20 percent of all hospitalizations in the U.S. 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, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever. 

IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

• Acetaminophen is contraindicated in patients with:
  • known hypersensitivity to acetaminophen or to any of the excipients in the IV 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 (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance = 30 mL/min).
• Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be fatal.
• 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.
• The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

• Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
• Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

• Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
• Breastfeeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
• Pediatric Use: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

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, as well as nuclear imaging products. 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; analgesics and hemostasis products; and central nervous system drugs. 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 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.

CONTACTS

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

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

[1] The IHI Triple Aim is a framework developed by the Institute for Healthcare Improvement that describes an approach to optimizing health system performance. It is IHI's belief that new designs must be developed to simultaneously pursue three dimensions, which the IHI calls the "Triple Aim":

• Improving the patient experience of care (including quality and satisfaction);
• Improving the health of populations; and
• Reducing the per capita cost of health care.

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SOURCE Mallinckrodt Pharmaceuticals