Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
"The approval of OFIRMEV is a significant milestone for Cadence as we advance our mission to improve the lives of hospitalized adults and children," said Ted Schroeder, President and CEO of Cadence. "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, particularly postoperative pain, often requires a multi-modal approach in which two or more analgesics are used with the goal of providing better analgesic efficacy. U.S. physicians already prescribe acetaminophen frequently in combination with opioids 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 Supporting FDA Approval
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, OFIRMEV 1000 mg every six hours was statistically superior to placebo for the reduction of pain intensity over 24 hours (p<0.01) with significantly reduced morphine consumption (33% over 24 hours, p<0.01). In a second study of 244 patients undergoing abdominal laparoscopic surgery, OFIRMEV 1000 mg every six hours, or 650 mg every four hours, demonstrated a significant reduction in pain intensity over 24 hours compared to placebo (p<0.02).
In a study of adult volunteers with induced fever, a single dose of OFIRMEV 1000 mg demonstrated a statistically significant reduction in temperature through six hours in comparison to placebo (p<0.01), 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 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.
Future Commitments
As required under its existing license agreement for OFIRMEV, Cadence will make a milestone payment of $15 million as a result of the U.S. approval of the product.
In accordance with a Pediatric Research Equity Act (PREA) requirement included in the new drug application (NDA) approval for OFIRMEV, Cadence will conduct a post-marketing efficacy study of OFIRMEV in infants and neonates. The company expects to commence this study in 2011.
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