Cumberland announces publication of results from study of Caldolor

Cumberland Pharmaceuticals announced the publication of positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborn infants, published in the journal Pediatric Drugs. Caldolor injection, is an intravenous non-steroidal anti-inflammatory drug, NSAID, approved by the FDA for the treatment of pain and fever in adults and children. The results of this published study supported the recent FDA approval of Caldolor in infants 3 to 6 months of age. “We’re excited to publish the results of this study highlighting the safety and the drug exposure profile of Caldolor in infants 1 to 6 months of age,” said senior author Dr. John Zhong, Associate Professor of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Children’s Health of Dallas. “Caldolor provides an important new weapon in the armamentarium of clinicians treating this pediatric population for fever and pain. Treating pain synergistically with other non-opioid regimens can potentially lower narcotic consumption in this most vulnerable age group.” The clinical study evaluated the safety and drug exposure profile of Caldolor in 24 hospitalized infants between the ages of 1 and 6 months who required treatment for pain or fever. Of the 24 patients included in the study, three were under 3 months of age, and the remaining 21 patients were 3 to 6 months of age. Twenty patients received a single dose, and four patients received multiple doses. In this study, single and multiple 10 mg/kg doses of Caldolor are reported safe, with no drug-related adverse events or renal concerns. Drug exposure following a single dose of Caldolor in infants 1 to 6 months of age was similar to what was previously reported in older children3.