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.
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 Resear
|SOURCE Cadence Pharmaceuticals, Inc.|
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