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Newly Published Data Demonstrates Caldolor® Significantly Reduces Pain and Morphine Use in Post-Operative Patients
Date:1/27/2011

g of IV ibuprofen or placebo every six hours after undergoing total abdominal hysterectomy surgery. All participants had open access to morphine.

The study met its primary endpoint of reducing morphine consumption within the first 24 hours following surgery. The median morphine requirement was significantly reduced by 19% in patients who received IV ibuprofen compared with those who received morphine alone.

The study also met its secondary endpoints of significantly reducing pain intensity at rest and with movement as measured on the visual analog scale (VAS) in patients receiving IV ibuprofen compared to placebo. Time to ambulation was also significantly faster in patients receiving IV ibuprofen. Similar treatment emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events. There was no difference between the two groups with respect to blood pressure, bleeding, or bruising, which are sometimes associated with use of oral ibuprofen.

"This study asserts not only that Caldolor provides a valuable morphine-sparing effect, but that it also provides better pain relief than morphine alone," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Publication of this relevant information provides us with an important new tool in a growing body of literature to help communicate the safety, efficacy and overall value of Caldolor to the medical community."

This new data affirms previous findings published in Clinical Therapeutics in October 2009. That study concluded that patients who underwent orthopedic and abdominal surgeries required less narcotic and experienced less pain with 800 mg of IV Ibuprofen every six hours compared to morphine alone.

The newly published study, entitled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen (IV-Ibuprofen) in the Management of Postoperative Pain Following Abdominal Hys
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SOURCE Cumberland Pharmaceuticals Inc.
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