FDA Approves First Intravenous Formulation of Acetaminophen

Yael Waknine

November 04, 2010

November 4, 2010 — The US Food and Drug Administration (FDA) has approved the first and only intravenous formulation of acetaminophen (Ofirmev; Cadence Pharmaceuticals, Inc) for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

Acute pain, particularly postoperative pain, is often treated with oral acetaminophen in combination with opioids. The availability of intravenous acetaminophen in the first quarter of 2011 is expected to fill a significant therapeutic gap.

"Ofirmev is a long-awaited and much needed addition to postoperative pain management," said Eugene R. Viscusi, MD, in a company news release. "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." Dr. Viscusi is director of Acute Pain Management at Thomas Jefferson University in Philadelphia, Pennsylvania.

FDA approval was based on data from a 3-study clinical trial program of 1020 adult and 355 pediatric patients.

In a study of 101 orthopedic patients undergoing either hip or knee replacement surgery, 1000 mg intravenous acetaminophen administered every 6 hours was significantly more effective than placebo for reducing pain intensity over the course of 24 hours (P < .01), resulting in a 33% decrease in morphine consumption (P < .01).

These findings were supported by data from a second study of 244 patients undergoing abdominal laparoscopic surgery showing that use of intravenous acetaminophen (1000 mg every 6 hours or 650 mg every 4 hours) was significantly more effective than placebo for decreasing pain intensity over the course of 24 hours (P < .02).

The third study, conducted in adult volunteers with induced fever, showed that a single dose of 1000 mg intravenous acetaminophen took effect within 15 minutes and yielded a significant decrease in temperature for 6 hours, relative to placebo (P < .01).

Use of intravenous acetaminophen in pediatric patients older than 2 years is supported by data from adult clinical trials and additional safety and pharmacokinetic data for this age group, company officials said in the news release, noting that a postmarketing efficacy study will be conducted in infants and neonates.

Intravenous acetaminophen should be administered only as a 15-minute infusion. As with other formulations of acetaminophen, the daily dose should not exceed 4 g because of the potential for potentially severe hepatotoxicity.

Adverse events most commonly reported in adult clinical trials included nausea, vomiting, headache and insomnia; nausea, vomiting, constipation, pruritus, agitation, and atelectasis were most commonly reported in pediatric patients.

Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease, and those with known hypersensitivity to formulation excipients or the drug itself. Treatment should be immediately discontinued if allergic or hypersensitivity reactions occur.

Caution is advised when treating patients with hepatic impairment or active liver disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment.

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