Efficacy data of Caldolor Injection in treating fever associated with falciparum malaria published

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that data supporting the efficacy of Caldolor in treating fever associated with falciparum malaria was published in the July edition of the peer-reviewed American Journal of Tropical Medicine and Hygiene. The study, which is the first to document an antipyretic effect of an injectable non-steroidal anti-inflammatory drug (NSAID) on fever caused by malaria, demonstrated that patients who received intravenous ibuprofen experienced a greater reduction in their temperatures than those who received placebo.

According to the Centers for Disease Control, there are 300 to 500 million cases of malaria each year worldwide and more than 1 million people die from it. Fever is one of the most common symptoms of the disease and many patients with severe malaria may deteriorate when their fever rises. Falciparum malaria is the most serious type of malaria and can be fatal within a few hours of the first symptoms. Currently, few options exist to treat fever in hospitalized patients who are unable to swallow or retain oral antipyretic therapy.

"Controlling fever and its associated symptoms is extremely critical in patients suffering from falciparum malaria," said Dr. David A. Warrell, Emeritus Professor of Tropical Medicine in the Nuffield Department of Clinical Medicine at the University of Oxford in the U.K., and lead author on the study. "Injectable ibuprofen provided rapid and well tolerated relief of fever for these patients and represents an especially important antipyretic treatment alternative for patients who are unable to take oral medicines."

The newly published data support findings from other previously published studies on the effectiveness of Caldolor® (ibuprofen) Injection for the treatment of both fever and pain. Designed for use in the hospital setting, Caldolor was approved by the U.S. Food and Drug Administration and launched by Cumberland in the United States in 2009. Caldolor is the first and only U.S.-approved injectable fever treatment and has been shown to significantly reduce pain and morphine use in the treatment of pain in adults.

"These findings validate our belief that Caldolor is a safe and effective way to reduce fever in patients suffering from a range of illnesses," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We believe the data supporting the efficacy of IV ibuprofen to reduce fever in critically ill malaria or sepsis patients offer strong support for its use in treating fever from a variety of sources, especially in patients who cannot tolerate oral medications."

A previous study, entitled "The Effects of Ibuprofen on the Physiology and Survival of Patients with Sepsis," was published in Volume 336, Number 13 of The New England Journal of Medicine. The results from that trial demonstrated that injectable ibuprofen reduced fever, pulse rate, and lactic acidosis in patients with sepsis, and was not associated with significant nephrotoxicity, gastrointestinal bleeding, transfusion requirements or other serious adverse events.

The newly published, double-blind, placebo-controlled malaria trial evaluated 60 hospitalized adults with acute uncomplicated falciparum malaria who were treated with artemisinin combination therapy. Thirty patients received 400 mg of intravenous ibuprofen and 30 received placebo every six hours for 72 hours. Patients who received IV ibuprofen experienced a greater reduction in fever than those who received placebo during the first 24 hoursIntravenous Ibuprofen (IV ibuprofen) Controls Fever Effectively in Adults with Acute Uncomplicated Plasmodium falciparum Malaria but Prolongs Parasitemia," can be found online at www.ajtmh.org.