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Caldolor® Clinical Study in Hospitalized Burn Patients Published in Journal of Burn Care & Research
Date:5/16/2011

NASHVILLE, Tenn., May 16, 2011 /PRNewswire/ -- 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
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SOURCE Cumberland Pharmaceuticals Inc.
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