Newly Published Data Demonstrates CaldolorÃ‚® Significantly Reduces Pain and Morphine Use in Post-Operative Patients
NASHVILLE, Tenn., Jan. 27, 2011 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced the publication of data affirming the safety and efficacy of Caldolor® (ibuprofen) Injection in treating post-operative pain in hospitalized patients. A Phase III study published in the peer-reviewed journal Pain Practice concluded that IV ibuprofen significantly reduced both morphine use and self-reported pain intensity in patients recovering from abdominal hysterectomy compared to morphine alone. Designed primarily for use in the hospital setting, Caldolor is the only FDA approved injectable ibuprofen product for treatment of both pain and fever.
In the United States, approximately 80% of patients experience pain following surgery, with 86% of these patients reporting moderate to severe pain(1,2). Both the World Health Organization and the American Society of Anesthesiologists Task Force recommend a multi-modal approach to pain management, with non-opioid analgesics such as ibuprofen recommended as first-line treatment(3,4).
"This study offers further evidence that a multi-modal analgesic regimen comprised of Caldolor in addition to opioid treatment is effective in managing acute post-operative pain," said Peter B. Kroll, M.D., Director of Comprehensive Pain Specialists in Hendersonville, Tenn., and lead author of the study. "In addition to reducing opioid use and pain intensity, IV ibuprofen blocks inflammation. Opioids alone do not address the inflammatory cascade that occurs during surgery, and uncontrolled inflammation may lead to inadequate pain control and pain progression. Managing inflammatory response may reduce the need for opioids, improve recovery and speed time to ambulation."
The multicenter, randomized, double-blind, placebo-controlled trial evaluated the safety and efficacy of IV ibuprofen as a post-operative analgesic. A total of 319 patients were randomized to receive 800 m