The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants.
Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.
The newly approved label features information about the product’s indications and usage, suitable patient groups, clinical trial results, potential side effects and patient safety details along with instructions for use.
Caldolor is the only non-opioid solution approved for the treatment of pain in infants that is administered through injection.
Cumberland sponsored a multi-centre trial in 21 hospitalised infants in order to validate its expanded usage.
All but one patient in the trial received a single dose of Caldolor.
The trial has confirmed its safety and efficacy for the treatment of pain and fever in the targeted patients.
The utilisation of the product for these indications is authenticated by data from one adequate and controlled open-label trial in infants, as well as additional safety data from four trials in 164 paediatric patients and supportive paediatric information from other approved ibuprofen products.
Cumberland Pharmaceuticals CEO A J Kazimi stated: “We believe that this approval for the product’s use in infants speaks to Caldolor’s favourable safety profile for use in a growing number of patient populations.”
Caldolor has already obtained FDA approval for pre-operative administration.
The non-narcotic pain reliever can be given just before surgery, helping patients wake from their procedures in reduced pain.
Cumberland expects Caldolor to become eligible for special Medicare reimbursement under the US Non-Opioids Prevent Addiction in the Nation Act (NOPAIN Act).