Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced results from a meta-analysis comparing the efficacy and safety of ibuprofen and acetaminophen, which was published in the March edition of the peer-reviewed journal The Annals of Pharmacotherapy. The publication notes that in a majority of evaluated studies ibuprofen demonstrated superior efficacy compared to acetaminophen for the treatment of pain and fever, and found no significant safety differences between the drugs.
The data supports findings from several previously published studies on the effectiveness of Caldolor® (ibuprofen) Injection for the treatment of pain and fever. Designed for use in the hospital setting, Caldolor was approved by the U.S. Food and Drug Administration (FDA) 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 both pain and morphine use in the treatment of pain in adults.
"With the safety of acetaminophen coming under scrutiny recently at an FDA advisory panel meeting, we are pleased that this new data supports the safety and efficacy of ibuprofen as an analgesic and antipyretic," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "This study supports our belief that Caldolor is a valuable option for physicians in the treatment of pain and fever in adults."
The new publication examined 85 published studies that directly compared oral ibuprofen to oral acetaminophen in the areas of analgesic efficacy, antipyretic efficacy and safety in both adult and pediatric populations. Qualitative review revealed that a majority of the studies concluded ibuprofen is more efficacious than acetaminophen for the treatment of pain and fever in adult and pediatric populations. Meta-analyses on a subset of qualifying studies confirmed these findings and also showed no significant differences in adverse event incidence.
Cumberland Pharmaceuticals Inc.