The FDA has approved Ofirmev (acetaminophen, from Cadence Pharmaceuticals) injection for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever in patients >2 years of age. This approval was based on data from clinical trials in which a total of 1,020 adult and 355 pediatric patients received IV acetaminophen.

In a study of 101 orthopedic patients undergoing hip or knee replacement surgery, Ofirmev 1000mg 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 1000mg every six hours, or 650mg 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 1000mg 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 is expected to be available in the first quarter of 2011.

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