Caldolor® Approved by FDA for Fever and Pain in Infants


Kaldor® The only non-opioid injectable approved to treat pain in infants

Nashville, Tennessee., May 15, 2023 /PRNewswire/ — 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 caldrol.®, an intravenous formulation of ibuprofen, now also included for use in infants. This non-narcotic drug may now be administered to treat pain and fever in patients aged 3 to 6 months.

The new FDA-approved label includes information on the product’s indications and uses, appropriate patient populations, clinical study results, potential side effects, patient safety details, and instructions for use with these infants. is included.

To support this expanded use of caldrol, Cumberland sponsored a multicenter study of 21 hospitalized infants. All but one patient were treated with a single dose of product.

The safety and efficacy of caldrol are now established in the treatment of pain and fever in pediatric patients aged 3 months and older. The use of caldrol for these indications is supported by additional safety data from four studies of 164 pediatric patients, supportive pediatric data from other approved ibuprofen products, and Supported by evidence from one open-label study in well-controlled infants. Controlled studies in adults.

Importantly, with this newly approved labeling, caldrol is that’s all A non-opioid product approved to treat pain in infants delivered by injection. Ketorolac and meloxicam are not approved for use in children because their safety and effectiveness in pediatric patients have not been established. Acetaminophen injections are not approved for the treatment of pain in children under 2 years of age because their safety and efficacy for treating pain in pediatric patients have not been established.

“We are pleased to offer Caldrol to these youngest patients,” said AJ Kazimi, CEO of Cumberland Pharmaceuticals. “We believe the approval of this product for use in infants speaks to the favorable safety profile of caldrol for use in a growing patient population.”

Cumberland FDA approval was previously announced for use in preoperative administration. Non-narcotic analgesics may be given just before surgery, allowing the patient to wake up from surgery with significant pain relief. Caldrol may be a safer alternative to opioids for pain control, as the FDA recently requested new safety warnings regarding the use of opioids.

In addition, the company recently reported that it expects Caldrol to be eligible for the following special Medicare reimbursements: Non-Opioids Prevent Addiction in National Laws (“NOPAIN Act”), enacted as part of the Consolidated Appropriations Act of 2023.

The NOPAIN Act requires Medicare to provide separate reimbursement for non-opioid products used for pain management during surgery performed in a hospital’s outpatient department or ambulatory surgery center. The reimbursement method for non-opioid alternative pain relievers under the NOPAIN Act applies to products offered during the following periods: January 1, 2025 and January 1, 2028. In 2024, the Centers for Medicare and Medicaid Services (CMS) is expected to implement the NOPAIN Act and issue regulations detailing the terms and amounts of individual reimbursements.

Caldrol is currently approved by the U.S. Food and Drug Administration (FDA) for use in adults and pediatric patients 3 months of age and older, as monotherapy for the management of mild to moderate pain, and moderate to severe pain. It is approved as a monotherapy for the management of Opioid adjuvant. A series of published clinical studies demonstrated that caldrol significantly reduced patients’ pain while also significantly reducing their need for opioids.

Full prescribing and safety information can be found on the brand’s website at www.caldolor.com.

About Caldrol®

Caldrol is indicated for the management of mild to moderate pain, the management of moderate to severe pain as an adjunct to opioid analgesics, and the reduction of fever in adult and pediatric patients. This was the first FDA-approved intravenous therapy for fever. Caldrol is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, a history of asthma or other allergic-type reactions after taking aspirin or other NSAIDs. Caldrol is contraindicated in the perioperative period of coronary artery bypass graft (CABG) surgery. Caldrol is used in patients with a history of ulcer disease or gastrointestinal bleeding, patients with fluid retention or heart failure, the elderly, patients with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. It should be used with caution in patients. Blood pressure should be monitored during product treatment.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on providing quality prescription brands to improve patient care. The Company develops, acquires and commercializes brands for the hospital acute care, gastroenterology and rheumatology market segments. Our portfolio of FDA-approved brands includes:

  • Acetadote® (Acetylcysteine) injections for the treatment of acetaminophen poisoning.
  • Kaldor® (ibuprofen) injections for the treatment of pain and fever.
  • Vaprisol® (Conivaptan) injections to increase serum sodium levels in hospitalized patients with normovolemia and hypervolemic hyponatremia.
  • Vivativ® (telavancin) injection. For the treatment of certain serious bacterial infections, including nosocomial and ventilator-associated bacterial pneumonia, complex skin and skin structure infections.
  • crystallose® (Lactulose) For oral solutions that are prescription laxatives for the treatment of chronic and acute constipation.and
  • Omecramox®– Park(omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (Helicobacter pylori) infections and related duodenal ulcer disease.

For more information, in the Cumberland Please visit individual product websites for approved products, including full prescribing information. The link is on our website at www.cumberlandpharma.com.

The Company is also conducting a series of evaluations of its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne muscular dystrophy (“DMD”), systemic sclerosis (“SSc”), and aspirin-aggravated respiratory disease (“AERD”). A Phase II clinical program is also underway. ).

Forward-Looking Statements

This press release contains forward-looking statements, which are subject to and reflect certain risks. in the Cumberland It represents our current view of future events based on reasonable assumptions. There is no guarantee that these events will occur. As in any business, at every step, in the Cumberland Operations are subject to factors beyond our control and any or a combination of these factors could have a material impact. in the Cumberland result of the operation. These factors include market conditions, competition, and lack of manufacturer capacity. in the Cumberland Complying with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other aspects of our control, as detailed in the Company’s most recent forms; Maintenance of Impossible Events. 10-K and subsequent 10-Q filed with the SEC. We do not guarantee that the expected results will be achieved or that the expected effects will be obtained. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. We undertake no obligation to publicly revise these statements to reflect events after the date of this document.

Source: Cumberland Pharmaceuticals, Inc.



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