Cumberland Pharmaceuticals publishes data on its Phase III intravenous ibuprofen study

Cumberland Pharmaceuticals Inc.Oct 20 2009

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that its Phase III study on intravenous ibuprofen as a post-operative analgesic was published in Volume 31, Number 9 of the peer-reviewed journal Clinical Therapeutics, distributed in October. The study concludes that patients emerging from orthopedic and abdominal surgeries required less narcotic and experienced less pain with 800 mg of intravenous ibuprofen every six hours compared to morphine alone.

In the United States, approximately 80 percent of patients experience pain following surgery, with 86 percent 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.

"These clinical findings support the use of intravenous ibuprofen in achieving improved post-operative pain control," said Stephen Southworth, M.D., orthopaedic surgeon at the North Mississippi Sports Medicine & Orthopaedic Clinic, PLLC and lead author of the study. "IV ibuprofen is a valuable pain management option for physicians seeking a multi-modal approach to post-operative pain management for their orthopaedic and abdominal patients."

The goal of this study was to evaluate the safety and efficacy of two different doses of intravenous ibuprofen as an effective post-operative analgesic medication. It focused on the results of hospitalized patients undergoing orthopedic or abdominal surgery who were randomized to receive either a placebo or 400 or 800 mg of intravenous ibuprofen every six hours. All patients had access to morphine by patient controlled analgesia (PCA). The first dose of ibuprofen was administered intra-operatively at the initiation of surgical closure. The double-blind, placebo-controlled trial was conducted at 17 different sites in three countries on 406 patients who were scheduled to undergo elective, single-site orthopedic or abdominal surgery between February 2005 and September 2006.

Median morphine use and pain assessed at rest and with movement were significantly reduced during the first 24 hours after administration in patients who received the 800-mg dose of ibuprofen. Pain reduction with Caldolor was also significantly greater versus patients with open access to morphine.

According to the study, "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain," intravenous ibuprofen is safe and well-tolerated when administered intra- and post-operatively. There was no significant difference between placebo and IV ibuprofen in the number of patients with renal function abnormalities, bleeding adverse events or in the incidence of blood transfusions. The publication can be found online at www.clinicaltherapeutics.com.