Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced the publication of data affirming the safety and efficacy of Caldolor® (ibuprofen) Injection in treating fever in critically ill and non-critically ill adults. Published in the peer-reviewed journal Critical Care, the study showed that IV ibuprofen was significantly more effective at reducing fever in hospitalized patients than placebo.
"These findings demonstrate that Caldolor offers physicians a very useful alternative for treating fever in the intensive care unit (ICU) as well as in non-ICU patients, especially for those who are unable to tolerate oral therapies due to intubation, sedation, nausea and other factors," said Peter Morris, M.D., Associate Professor of Pulmonary, Critical Care, Allergy, and Immunologic Medicine at Wake Forest University and principal investigator of the study. "Rapid fever reduction can also help address discomfort often experienced by febrile patients."
The multi-center, randomized, double-blind, parallel, placebo-controlled trial evaluated three doses of IV ibuprofen to compare their effectiveness against placebo in reducing fever in 120 hospitalized ICU and non-ICU patients. Patients were randomized to receive 100 mg, 200 mg, 400 mg or placebo, and all patients had temperatures greater than or equal to 101.0 degrees F prior to treatment. Approximately 44% of participants were critically ill, defined as patients receiving mechanical ventilation and/or vasopressor support. The study met its primary endpoint as the 400 mg dose of study drug significantly reduced fever compared to placebo at 4 hours following administration of the first dose. Patients receiving 400 mg IV ibuprofen demonstrated a 77% reduction in temperature compared with 32% for the placebo group.
The study also met its secondary endpoints, as patients receiving the 200 mg dose of IV ibuprofen achieved a 70% reduction in temperature and those receiving the 100 mg dose experienced a 61% reduction. All doses of IV ibuprofen reduced temperatures at 24-hours, and the 400 mg dose was effective in lowering temperature to a normothermic range and maintaining this over 24 hours. There were no significant differences in renal function, bleeding or other serious adverse events between patients receiving IV ibuprofen and those receiving placebo. There were also no significant differences between treatment and placebo groups in terms of adverse event occurrence except for bacteremia (13% in the 100 mg group versus 0% in the placebo group), which was reported by site investigators to be consistent with underlying disease and not related to study drug.
"This data is the latest in a growing body of evidence supporting the safety and efficacy of Caldolor in treating both fever and pain in hospitalized patients," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We are pleased to provide physicians with additional support for Caldolor as a new alternative for reducing fever in hospitalized patients."
Designed primarily for use in the hospital setting, Caldolor is the first FDA approved injectable product for treatment of both pain and fever and is the only intravenous therapy approved for the reduction of fever in the United States.
Cumberland Pharmaceuticals Inc.