Caldolor: The Only Non-Opioid Injectable Pain Reliever Approved for Use in Infants, Says FDA

The FDA has approved expanded labeling for Cumberland Pharmaceuticals Inc's CPIX Caldolor, an intravenously delivered formulation of ibuprofen, to now include use in infants. 

The non-narcotic agent may now be administered to treat pain and fever in patients three months to six months of age. 

To support this expanded use of Caldolor, Cumberland sponsored a multi-center study in 21 hospitalized infants. All but one patient was treated with a single dose of the product.

The use of Caldolor for these indications is supported by evidence from one adequate and controlled open-label study in infants, along with additional safety data from four studies in 164 pediatric patients, supportive pediatric data from other approved ibuprofen products, and evidence from adequate and well-controlled studies in adults.

With this newly approved labeling, Caldolor is the only non-opioid product approved to treat pain in infants delivered through injection. 

Cumberland previously announced FDA approval for use in pre-operative administration. The non-narcotic pain reliever may be administered just before surgery, enabling patients to wake up from their procedures in significantly less pain. 

In addition, the company recently reported that it expects Caldolor to be eligible for special Medicare reimbursement under the Non-Opioids Prevent Addiction in the Nation Act (the NOPAIN Act), enacted as part of the Consolidated Appropriations Act of 2023.

Price Action: CPIX shares are up 8.59% at $1.79 on the last check Monday.