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,â€ 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.