Phase III study affirms safety and efficacy of Cumberland's Caldolor for post-operative pain

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. 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.

"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 mg 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 Hysterectomy," appears in Volume 11 of Pain Practice, and is available at http://onlinelibrary.wiley.com/doi/10.1111/j.1533-2500.2010.00402.x/abstract.