FDA Approves Acetaminophen Injection for the Management of Pain, Fever
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FDA Approves Acetaminophen Injection for the Management of Pain, Fever

NEW YORK -- November 2, 2010 -- The US Food and Drug Administration (FDA) has approved an intravenous formulation of acetaminophen (Ofirmev) for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

“[Injectable acetaminophen] is a long-awaited and much needed addition to postoperative pain management,” said Eugene R. Viscusi, MD, Acute Pain Management, Thomas Jefferson University, Philadelphia, Pennsylvania. “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.”

The approval was based on data trials in which a total of 1,020 adult and 355 paediatric patients received intravenous acetaminophen. These trials included 2 studies evaluating the safety and effectiveness of injectable acetaminophen in the treatment of pain, and 1 study evaluating the intravenous drug in the treatment of fever.

In a study of 101 orthopaedic patients undergoing hip or knee replacement surgery, injectable acetaminophen 1000 mg every 6 hours was statistically superior to placebo for the reduction of pain intensity over 24 hours (P <.01) with significantly reduced morphine consumption (33% over 24 hours; P <.01).

In a second study of 244 patients undergoing abdominal laparoscopic surgery, injectable acetaminophen 1000 mg every 6 hours, or 650 mg every 4 hours, demonstrated a significant reduction in pain intensity over 24 hours compared with placebo (P <.02).

In a study of adult volunteers with induced fever, a single dose of intravenous acetaminophen 1000 mg demonstrated a statistically significant reduction in temperature through 6 hours in comparison with placebo (P <.01), with an onset of action within 15 minutes after treatment.

The intravenous formulation was well tolerated in clinical trials.

SOURCE: Cadence Pharmaceuticals, Inc.

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