The Food and Drug Administration (FDA) has approved the use of the injection of acetaminophen, the drug found in Tylenol, for the management of pain, and the reduction of fever.

Sold under the brand name OFIRMEV by Cadence Pharmaceuticals, Inc., this is the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. 

"IV acetaminophen is the unit market share leader among all injectable pain medications in Europe,” said Ted Schroeder, President and CEO of Cadence. "With our planned launch early in the first quarter of 2011, we believe that OFIRMEV will fill a significant gap in the United States for the treatment of pain and fever in the hospital setting."

Need for better pain management

Acute pain, particularly following surgery, often requires treatment with two or more painkillers. U.S. physicians already prescribe acetaminophen frequently in combination with opioids -- or opium-based painkillers -- for oral management of pain, where it is the most widely used non-opioid in fixed combination therapies. In clinical studies, OFIRMEV improved pain relief, reduced opioid consumption, and improved patient satisfaction when used as part of a multi-modal regimen.

"OFIRMEV is a long-awaited and much needed addition to postoperative pain management," said Eugene R. Viscusi, M.D., director of Acute Pain Management at Thomas Jefferson University in Philadelphia. "With the approval of OFIRMEV, clinicians will now be better able to use a multi-modal approach to pain management in the hospital setting, when oral medication can't be used." 

Clinical trial results

The FDA approval of OFIRMEV was based on data from clinical trials in which a total of 1020 adult and 355 pediatric patients received IV acetaminophen. These trials included two studies evaluating the safety and effectiveness of OFIRMEV in the treatment of pain, and one study evaluating OFIRMEV in the treatment of fever.

In a study of 101 orthopedic patients undergoing hip or knee replacement surgery, 1000 mg of OFIRMEV every six hours was statistically superior to placebo for the reduction of pain intensity over 24 hours with significantly reduced morphine consumption.  In a second study of 244 patients undergoing abdominal laparoscopic surgery, 1000 mg of OFIRMEV every six hours, or 650 mg every four hours, demonstrated a significant reduction in pain intensity over 24 hours compared with placebo.

In a study of adult volunteers with induced fever, a single 1000 mg dose of OFIRMEV demonstrated a statistically significant reduction in temperature through six hours in comparison with placebo with an onset of action within 15 minutes after treatment.

OFIRMEV was well tolerated in clinical trials assessing safety in a range of patient and surgery types.

The safety and effectiveness of OFIRMEV for the treatment of pain and fever in pediatric patients older than two years is supported by evidence from adequate and well-controlled studies in adults and additional safety data for this age group. The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients under two years of age.