Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) today announced that results from a clinical study evaluating the safety and efficacy of Caldolor® (ibuprofen) Injection in treating fever and pain in hospitalized burn patients was published in Volume 32, Number 1 of the Journal of Burn Care & Research. The study demonstrated that Caldolor significantly reduces fever in these patients, including those with severe thermal burns. The newly published study also supports the safety of Caldolor as it involved the highest dose and duration of exposure to IV ibuprofen to date, demonstrating that the recommended maximum daily dose of 3200mg/day over five days of treatment was well tolerated.
"Immediate and sustained regulation of body temperature and reduction of fever following a burn injury is critical to patient recovery as well as comfort," said Dr. John T. Promes, principal investigator of the study, Director of Trauma Services and Associate Director for Surgical Education at Orlando Regional Medical Center, Assistant Professor of Surgery at the University of Central Florida College of Medicine, and Clinical Assistant Professor in the Department of Surgery at the Florida State University College of Medicine. "Because oral administration of antipyretics in hospitalized burn patients is often impossible due to sedation, intubation and a variety of factors, IV fever reduction with an agent such as Caldolor is not only convenient but often necessary. Further, as a non-steroidal anti-inflammatory drug (NSAID), Caldolor has the potential to arrest the cascade of inflammation caused by burn injury and thereby alleviate pain in addition to fever."
The prospective, multicenter, randomized, double-blind, placebo-controlled trial was conducted at five U.S. and international sites, including hospital burn units and burn centers. The study evaluated 61 adult burn patients with second or third degree burns covering more than 10 percent total body surface area with an anticipated hospital stay of more than 72 hours and fever evidenced by temperatures of 38.0 degrees C (100.4 degrees F) or greater. Patients were administered 800mg of Caldolor every six hours for five consecutive days. The primary efficacy endpoint of the study was to reduce fever as measured by area under the curve for temperature (AUC-T degrees) over the first 24 hours of treatment, compared with a target temperature of 37.0 degrees C (98.6 degrees F). Statistical significance was achieved for the primary endpoint of the study, as there was a significant reduction in temperature (AUC-T degrees, 0-24 hours) in patients receiving Caldolor compared with those receiving placebo. Caldolor was well tolerated and there was no significant difference in adverse events between patients receiving placebo and those receiving Caldolor.
"The publication of this study supports hospital physicians' ability to rely on Caldolor to treat burn patients, who often suffer from both fever and pain," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "These study results supporting use of Caldolor to treat fever in this patient population offer strong evidence of both efficacy and safety, and the product stands to help thousands of patients suffering from severe burns."
According to the American Burn Association, 1.1 million burn injuries require medical attention each year in the United States. Of these, approximately 50,000 burn injuries require hospitalization, 20,000 are major burn injuries affecting 25 percent of total body surface area and 4,500 people die. In addition, up to 10,000 people in the United States die every year from burn-related infections.
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