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Caldolor® Now FDA Approved For Treatment Of Fever & Pain In Infants

Tuesday, May 16, 2023

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Caldolor®, an intravenously delivered formulation of ibuprofen, to now include use in infants. The non-narcotic agent may now be administered for the treatment of pain and fever in patients three months to six months of age.  

The newly FDA-approved label includes information regarding the product's indications and usage, appropriate patient populations, clinical study results, potential side effects, patient safety details, and instructions for use in these young children.

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 safety and efficacy of Caldolor has  now been established for the treatment of pain and fever in pediatric patients aged 3 months and older. 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.

Importantly with this newly approved labeling, Caldolor is the only non-opioid product approved to treat pain in infants that is delivered through injection. Ketorolac and meloxicam are not approved for use in children, as the safety and efficacy of those drugs have not been established for pediatric patients.  Acetaminophen injection is not approved for treating pain in children less than 2 years of age, as the safety and efficacy of that drug has not been established for treating pain in those pediatric patients.

"We are delighted to provide Caldolor for these youngest of patients," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals. "We believe that this approval for the product's use in infants speaks to Caldolor's favorable safety profile for use in a growing number of patient populations."

Cumberland previously announced FDA approval for use in pre-operative administration. The non-narcotic pain reliever may be administered just prior to surgery, which enables patients to wake up from their procedures in significantly less pain. Caldolor presents a potentially safer alternative to opioids for controlling pain, as the FDA has recently required new safety warnings on the use of opioids.

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

The NOPAIN Act requires Medicare to provide separate reimbursement for non-opioid products that are used to manage pain during surgeries conducted in outpatient hospital departments or in ambulatory surgical centers. The methodology for reimbursement for non-opioid pain alternatives under the NOPAIN Act will apply to those products that are furnished between January 1, 2025 and January 1, 2028. It is anticipated that in 2024, the Centers for Medicare & Medicaid Services (CMS) will issue regulations implementing the NOPAIN Act and detailing the conditions for, and amount of, the separate reimbursement.

Caldolor is now approved by the U.S. Food and Drug Administration (FDA) for use in adults and pediatric patients three months and older, for the management of mild to moderate pain as a sole therapy, and for the management of moderate to severe pain as an adjunct to an opioid. A series of published clinical studies have demonstrated that Caldolor significantly reduces patient pain, while also significantly reducing patients' need for opioids.

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