Caldolor® Demonstrates Favorable Safety Profile In Newborns

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) today announced topline results from a clinical study evaluating the safety and pharmacokinetics of Caldolor® (ibuprofen) Injection in children ranging from birth to six months of age. Topline results from this study indicate that Caldolor was well tolerated overall in this patient population, with no safety concerns noted.

The open-label trial enrolled 24 newborns at four medical centers across the country. The study data  indicated that the pharmacokinetics of Caldolor behaves similarly between these very young children and those greater than 6 months of age. Next steps include finalizing the full study report for submission to the FDA and then determining whether an additional pediatric indication will be available.

"We remain committed to the ongoing development of our brands, and are working to make them available to new patient populations," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals.

At the time of Caldolor's New Drug Application (NDA) approval, the FDA requested a series of Phase IV studies to evaluate the product in pediatric patients. Cumberland had previously completed a pain and a fever study leading to an expanded Caldolor label - with FDA approval - for use in children 6 months and older. Cumberland completed the last of these requirements through this clinical study of the use of Caldolor in the youngest of patients.