Mallinckrodt Presents Health Economic Data on OFIRMEV (acetaminophen) Injection at ASRA 16th Annual Pain Medicine Meeting

STAINES-UPON-THAMES, United Kingdom, Nov. 16, 2017 /PRNewswire/ -- Mallinckrodt (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) 16^th 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

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