Ofirmev (acetaminophen) Injection Approved For Pain And Fever By FDA

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Main Category: Pain / Anesthetics
Also Included In: Neurology / Neuroscience;  Bones / Orthopedics
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Intravenous Ofirmev (acetaminophen) has been approved by the Food and Drug Administration (FDA) for the management of mild to moderate pain, fever reduction, and the management of moderate to severe pain when in combination with opioid analgesics. Acetaminophen's international non-proprietary name is paracetamol.

President and CEO of Cadence Pharmaceuticals, the makers of Ofirmev, Ted Schroeder, said:

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.

Acute pain - pain that comes on rapidly, may be severe, but is not long-lasting - especially post-operative pain, often requires at least two painkilling medications for effective pain relief. Acetaminophen is commonly prescribed, regularly in combination with oral opioids for pain management.

Cadence informs that clinical studies demonstrated that Ofirmev not only improved pain relief, but also reduced opioid consumption. The trials reported better patient satisfaction when Ofirmev formed part of a multi-modal regimen.

Director of Acute Pain Management at Thomas Jefferson University in Philadelphia, Eugene R. Viscusi, M.D., said:

Ofirmev is a long-awaited and much needed addition to postoperative pain management. 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.

The Ofirmev trials included 1020 adults and 355 children - they were all administered IV (intravenous) acetaminophen. Two studies examined the safety and efficacy of Ofirmev in pain treatment, while another study evaluated Ofirmev for the treatment of fever.

Ofirmev 1000mg every six hours was significantly superior to a placebo in reducing pain intensity over a 24-hour period in patients undergoing hip/knee replacement surgery. In another study involving 244 patients who underwent abdominal laparoscopic surgery, either 1000mg of Ofirmev every six hours or 650mg every four hours, Ofirmev was considerably better in reducing pain intensity compared to a placebo over a 24-hour period.

A study involving adult participants who volunteered to be induced into a fever, demonstrated significantly superior results for those on Ofirmev 1000mg compared to those on a placebo. Symptom reduction was observed within 15 minutes of receiving the Ofirmev injection.

Cadence adds that clinical trials showed that Ofirmev was found to be well tolerated in a wide range of surgery types and patient types.

Regarding pediatric use, Cadence wrote in a communiqué:

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 and pharmacokinetic data for this age group. The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than two years of age.

Source: Cadence Pharmaceuticals

Written by Christian Nordqvist
Copyright: Medical News Today
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