Cumberland Pharmaceuticals has reported positive results from the trial of Caldolor (ibuprofen) Injection in children ranging from birth to six months of age.
The open-label trial, which evaluated the safety and pharmacokinetics of Caldolor, enrolled 24 newborns at four medical centres across the country.
The study found that the therapy was well tolerated overall in this patient population, with no safety concerns reported.
Furthermore, the pharmacokinetics of Caldolor behaved similarly between infants and those greater than six months of age.
Cumberland Pharmaceuticals CEO AJ Kazimi said: “We remain committed to the ongoing development of our brands and are working to make them available to new patient populations.”
Caldolor is a FDA-approved intravenous therapy for fever. It is indicated in adults and paediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as for the reduction of fever.
The US Food and Drug Administration requested a series of Phase IV studies to evaluate the therapy in paediatric patients during its new drug application (NDA) approval.
Cumberland had previously completed a pain and a fever study, leading to an expanded Caldolor label for use in children six months and older.
The company completed the last of these requirements through the new clinical study.
After finalising the full study report for submission to the FDA, it will determine whether an additional paediatric indication is available for Caldolor.