Mallinckrodt plc a leading global specialty biopharmaceutical company announced the results from a retrospective analysis of health economic data on the use of OFIRMEV (acetaminophen) injection as part of multimodal analgesia (MMA) for the treatment of acute postoperative pain following elective orthopedic surgery.
The analysis, recognized as a top-scoring abstract during the peer-review process, was one of four selected for oral presentation and identified as an award recipient at the 2016 Annual Congress of Enhanced Recovery and Perioperative Medicine on Thursday, April 21, in Washington, DC.
World pharma today/Research Insight/-The Mallinckrodt-sponsored study, “Hospitalization Costs for Patients Undergoing Orthopedic Surgery Treated with Intravenous Acetaminophen (IV-APAP) Plus Other IV Analgesics or IV Opioids Alone for Postoperative Pain,” evaluated data from Truven Health’s MarketScan Hospital Drug Database (HDD) of approximately 600 participating hospitals and included more than 144,000 patients admitted and discharged for elective orthopedic surgery between Jan. 1, 2011 and Aug. 31, 2014. The retrospective analysis assessed hospitalization costs (medical plus pharmacy) among patients undergoing elective total knee replacement, total hip replacement or surgical repair of hip fracture who received multimodal postoperative pain management with the combination of OFIRMEV and other IV analgesics to those who received only IV opioids starting on the day of surgery. Both groups could receive oral analgesics as part of their postoperative pain management regimen. Though treatment groups were significantly different on all baseline characteristics (all P<0.001), including mean age, percent female and if the hospital was a teaching hospital, the numerical differences observed between groups may not be clinically meaningful.
Key findings associated with the use of multimodal analgesia, including OFIRMEV, versus IV opioids alone in the orthopedic postsurgical pain management setting were:
- Statistically significantly lower mean total hospitalization costs for patients in the OFIRMEV group compared to patients in the IV opioid-only group ($12,540 vs. $13,242; P<0.0001); and
- The difference in total costs was driven by lower medical costs such as reduced medical and surgical supplies, laboratory testing, imaging and other costs, which made up $701 of the $702 difference.
- Differences in hospitalization costs remained statistically significant after controlling for baseline differences in the multivariate analysis, with use of OFIRMEV as part of a multimodal analgesia approach associated with $830 less in hospitalization costs (P<0.0001).
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. 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.
- 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.
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.
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1Apfel C, et al. Effect of i.v. acetaminophen on total hip or knee replacement surgery: A case-matched evaluation of a national patient database. Am J Health-Syst Pharm. 2015; 72:1961-8.
2 Premier Healthcare Alliance [paid-access hospital research database: data from January 2011-March 2015]. Charlotte, NC: Premier, Inc. Updated June 2015.