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OFIRMEV® (Acetaminophen) Injection Health Economic Data Presented at Women’s Health 2016: The 24th Annual Congress

-- Retrospective data show that, when compared  to IV opioids alone, treating acute OB/GYN surgical pain with OFIRMEV and IV  opioids decreases hospital length of stay, costs and overall inpatient opioid  use --

CHESTERFIELD,  United Kingdom – April 18, 2016 - Mallinckrodt plc (NYSE: MNK), a  leading global specialty biopharmaceutical company, today announced the results  from a retrospective analysis of health economic data on the use of OFIRMEV  (acetaminophen) injection together with intravenous (IV) opioids for the  treatment of acute obstetrics and gynecology (OB/GYN) surgical pain. This retrospective  analysis is the first solely focused on this patient population for OFIRMEV. The  results were presented as a poster at the 24th Annual Congress of  the Academy of Women's Health: Women's Health 2016 on Saturday, April 16, in  Washington, DC.

The  study, "Comparative Analysis of  Inpatient Costs for Obstetrics and Gynecology Surgery Patients Treated with IV Acetaminophen  and IV Opioids Versus IV Opioids Alone for Postoperative Pain," undertaken  in collaboration with the University of Washington in Seattle, evaluated  data from the Premier Inpatient Hospitalization Database of more than 225,000 anonymous  female adult inpatient surgical admissions across U.S. hospitals from January  2009 to June 2015. The retrospective analysis assessed length of stay and related hospitalization costs among surgical OB/GYN patients who received  perioperative pain management with a combination of OFIRMEV and IV opioids compared  with those who received IV opioid monotherapy alone, starting on the day of  surgery and continuing up to the second post-operative day. Subjects  underwent Caesarean sections and total hysterectomies, averaged 36 years of age  and were predominately Caucasian (60 percent).

Key findings associated with use of OFIRMEV together  with IV opioids across these OB/GYN surgical patients were:

     
  • A  length of stay of 3.1  days versus 3.3 days for patients who received IV opioid monotherapy, lower by 0.20  days (p<0.0001)
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  • Hospitalization costs of $9,043 versus $9,546 for IV opioid  monotherapy, lower by $503 (p<0.0001); differences in hospitalization costs  remained statistically significant after controlling for confounders with  OFIRMEV associated with $484 less in hospitalization costs (p=0.0006); and
  •  
  • Decreased inpatient opioid utilization of 27.5 mg versus 29.6 mg  for IV opioid monotherapy, lower by 2.2 mg (p<0.0001).


  LIMITATIONS OF STUDY

     
  • The  differences observed between OFIRMEV and IV opioid monotherapy patients could  be explained by unmeasured confounders. Investigators attempted to account for  this through the use of instrumental variable regression, adjusting models 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 IV opioids between patients who did or did not receive OFIRMEV 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.  However, the database represents 20 percent of all hospitalizations in the U.S.
   

The average number of days a patient stays at the facility

   

ABOUT THE DATA
Comparative Analysis of Inpatient Costs for Obstetrics and Gynecology  Surgery Patients Treated with IV Acetaminophen and IV Opioids Versus IV Opioids  Alone for Postoperative Pain. Ryan N.  Hansen, PharmD, Ph.D. School of Pharmacy, University of Washington, Seattle, WA.

   

Abstract  available online (No. 37): http://online.liebertpub.com/doi/full/10.1089/jwh.2016.29006.abstracts

   

IMPLICATIONS OF THE DATA
This  analysis may offer important insight on possible ways to help provide savings  to the hospital system, reduce OB/GYN inpatient opioid use and improve OB/GYN patient  outcomes. The use of opioids alone has been a mainstay for acute pain  management. There  is an overreliance on opioids as monotherapy to treat acute pain in U.S.  hospitals today and 7 out of 10 hospital patients treated with IV analgesia  receive IV opioids alone.

   

ABOUT OFIRMEV (Acetaminophen)  Injection
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. OFIRMEV (acetaminophen) injection is the first and only  intravenous (IV) formulation of acetaminophen to be approved 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.

   

IMPORTANT RISK  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.

     
   

CONTRAINDICATIONS   

         
  • Acetaminophen is contraindicated in patients with:
  •          --known hypersensitivity to acetaminophen or to any of the  excipients in the intravenous (IV) formulation.
             --severe hepatic impairment or severe active liver disease.

         

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.
  •    

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 and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; 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; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit http://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.

 

CONTACTS
Media
Rhonda Sciarra
Senior Communications Manager
314-654-8618
rhonda.sciarra@mallinckrodt.com

Meredith Fischer
Senior Vice President, Communications and Public Affairs
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

1 The average number of days a patient stays at the facility
 2 Premier Healthcare Alliance [paid-access hospital research database: data from January 2011-March 2015].
    Charlotte, NC: Premier, Inc. Updated June 2015