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FDA Approves First Intravenous Formulation of Acetaminophen - Ofirmev

Posted Nov 04 2010 9:37pm

Cadence Pharma is located in San Diego and this looks to be a nice bridge for pain image relief instead of perhaps having to rely on a heavier type of pain reliever.  The trials were based around patients with orthopedic surgical procedures.  It will also serve to reduce fever and more information can be found at the website.  BD

From the website:

“OFIRMEV should be administered only as a 15-minute infusion.  Do not exceed the maximum recommended daily dose of acetaminophen.  Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.  OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation.”

November 4, 2010 — The US Food and Drug Administration (FDA) has approved the first and only intravenous formulation of acetaminophen image (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.

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