San Diego based company Cadence Pharmaceuticals Inc. (Nasdaq:CADX) has won the approval of the U.S. Food and Drug Administration (FDA) to market Ofirmev (acetaminophen), its injected drug for pain and fever relief.
The new drug is the only in intravenous (IV) formulation of acetaminophen to be cleared in the United States for treatment of moderate to severe pain.
Ofirmev will aid patients who cannot tolerate oral pain killers post operation and also provides doctor an alternative to opioid-based pain relievers that can be addictive and cause serious adverse events like chronic constipation.
Ted Schroeder, president and CEO of Cadence declared, "The approval of OFIRMEV is a significant milestone for Cadence as we advance our mission to improve the lives of hospitalized adults and children.
"IV acetaminophen is the unit market share leader among all injectable pain medications in Europe. 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."
Ofirmev will aid patients who cannot tolerate oral pain killers post operation and also provides doctor an alternative to opioid-based pain relievers that can be addictive and cause adverse events like chronic constipation.
Approval on the basis of clinical trials
The health regulators gave the green signal after assessing the safety data from 1375 patients who received IV acetaminophen in clinical trials, including 355 pediatric patients, from premature neonates to adolescents.
The trials included two pivotal studies for the treatment of acute pain in patients following orthopedic surgery and abdominal laparoscopic surgery and one pivotal clinical trial for the treatment of fever.
Outcome of the three studies
The intravenous formulation showed promising results in all the clinical trials.
The first study included 101 orthopaedic patients undergoing hip or knee replacement surgery. The patients were injected with 1000 mg of the pain killer every 6 hours.
The researchers found Ofirmev to be far superior to a placebo. It not only reduced the intensity of pain significantly over 24 hours but also cut the use of morphine (33 percent over 24 hours; P<.01).
In the second study 244 patients undergoing abdominal laparoscopic surgery were assigned to either a dose of1000 mg of injectable acetaminophen every 6 hours, or 650 mg every 4 hours.
Compared to a placebo, the painkiller exhibited a dramatic reduction in pain intensity over 24 hours (P <.02).
In the third study, adult volunteers with induced fever were given a single dose of intravenous acetaminophen 1000 mg.
It was observed that new drug lowered the temperature within six hours in comparison with placebo (P <.01).
The results were evident within 15 minutes of treatment.
Eugene R. Viscusi, MD, Acute Pain Management, Thomas Jefferson University, Philadelphia, Pennsylvania, stated, "[Injectable acetaminophen] is a long-awaited and much needed addition to postoperative pain management.
"With this approval, 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."