NASHVILLE, Tenn., June 26,
2023 /PRNewswire/ -- Cumberland Pharmaceuticals
Inc. (NASDAQ: CPIX), a specialty pharmaceutical company,
today 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 Drugs1. Caldolor (ibuprofen)
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
age2.
"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.
Administration of oral medications for the treatment of pain and
fever in hospitalized pediatric patients can be challenging.
Moreover, pain in pediatric populations is often poorly assessed
and undertreated or mismanaged, leading to adverse patient outcomes
(both long- and short-term) and increased healthcare expenditures.
The results of this study support the growing body of evidence
which demonstrate Caldolor is a safe therapeutic option available
to practitioners for the treatment of fever and pain in
children.
Full prescribing and safety information can be found at the
brand's website www.caldolor.com.
- Glover CD et al. A Multi-Center Evaluation of the
Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6
Months of Age. Pediatric Drugs. 9
June 2023.
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https://investor.cumberlandpharma.com/news-releases/news-release-details/caldolorr-now-fda-approved-treatment-fever-pain-infants
- Khalil SN et al. A multicenter, randomized, open-label,
active-comparator trial to determine the efficacy, safety, and
pharmacokinetics of intravenous ibuprofen for treatment of fever in
hospitalized pediatric patients. BMC Pediatr. 2017
Feb 1;17(1):42.
About Caldolor®
Caldolor is indicated in adults and pediatric patients for the
management of mild to moderate pain and management of moderate to
severe pain as an adjunct to opioid analgesics, as well as for the
reduction of fever. It was the first FDA-approved intravenous
therapy for fever. Caldolor is contraindicated in patients with
known hypersensitivity to ibuprofen or other NSAIDs, patients with
a history of asthma or other allergic-type reactions after taking
aspirin or other NSAIDs. Caldolor is contraindicated for use during
the peri-operative period in the setting of coronary artery bypass
graft (CABG) surgery. Caldolor should be used with caution in
patients with prior history of ulcer disease or GI bleeding, in
patients with fluid retention or heart failure, in the elderly,
those with renal impairment, heart failure, liver impairment, and
those taking diuretics or ACE inhibitors. Blood pressure should be
monitored during product treatment.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical
company focused on the delivery of high-quality prescription brands
to improve patient care. The Company develops, acquires, and
commercializes brands for the hospital acute care, gastroenterology
and rheumatology market segments. The Company's portfolio of
FDA-approved brands includes:
- Acetadote® (acetylcysteine)
Injection, for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) Injection,
for the treatment of pain and fever;
- Vaprisol® (conivaptan) Injection,
to raise serum sodium levels in hospitalized patients with
euvolemic and hypervolemic hyponatremia;
- Vibativ® (telavancin) Injection,
for the treatment of certain serious bacterial infections including
hospital-acquired and ventilator-associated bacterial pneumonia, as
well as complicated skin and skin structure infections;
- Kristalose® (lactulose) for Oral
Solution, a prescription laxative, for the treatment of chronic and
acute constipation; and
- Omeclamox®-Pak, (omeprazole,
clarithromycin, amoxicillin) for the treatment of Helicobacter
pylori (H. pylori) infection and related duodenal ulcer
disease.
- Sancuso® (granisetron) transdermal, for the
prevention of nausea and vomiting in patients receiving certain
types of chemotherapy treatment.
For more information on Cumberland's approved products, including full
prescribing information, please visit the individual product
websites, links to which can be found on the Company's website
www.cumberlandpharma.com.
The Company also has a series of Phase II clinical programs
underway evaluating its ifetroban product candidates in patients
with cardiomyopathy associated with Duchenne Muscular Dystrophy
("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated
Respiratory Disease ("AERD").
Forward-Looking Statements
This press release contains forward-looking statements, which
are subject to certain risks and reflect Cumberland's current views on future events
based on what it believes are reasonable assumptions. No assurance
can be given that these events will occur. As with any business,
all phases of Cumberland's
operations are subject to factors outside of its control, and any
one or combination of these factors could materially affect
Cumberland's results of
operations. These factors include market conditions, competition,
an inability of manufacturers to produce Cumberland's products on a timely basis or
failure of manufacturers to comply with regulations applicable to
pharmaceutical manufacturers, maintaining an effective sales and
marketing infrastructure, natural disasters, public health
epidemics, and other events beyond our control, as more fully
discussed in the Company's most recent Form 10-K and subsequent
10-Qs as filed with the SEC. There can be no assurance that results
anticipated by the Company will be realized or that they will have
the expected effects. Readers are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the
date hereof. The Company does not undertake any obligation to
publicly revise these statements to reflect events after the date
hereof.
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SOURCE Cumberland Pharmaceuticals Inc.