Growing data shows intravenous ibuprofen is
safe and effective for the treatment of pain and fever in
adults, children and infants
NASHVILLE, Tenn., April 2,
2024 /PRNewswire/ -- Cumberland
Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical
company, today announced the release of a Special Report evaluating
the growing amount of current data supporting the use of its
Caldolor® product (intravenous ibuprofen, or IVIB) as a
standard of care for the treatment of pain and fever in adults,
children and infants.
The report, published in Anesthesiology News, General
Surgery News and Pharmacy Practice News, highlights the
need for the prudent and careful management of pain, particularly
as the prescription of opioids for pain treatment has become
commonplace, often leading to dependence and misuse.
"My hope is that this Special Report will emphasize the use
of Caldolor as a foundation for multimodal pain management,
while also helping to address the opioid epidemic," said
Michael W. Lew, M.D., Clinical
Professor and Past Chair for the Department of Anesthesiology and
Perioperative Medicine at the City of Hope Cancer Center.
As part of a comprehensive safety and efficacy developmental
plan, IVIB was studied in various treatment areas, including
surgical pain, fever and nonsurgical acute pain. The results, which
are highlighted in the report, show it's a safe and effective
treatment for pain and fever in adults, children and infants as
young as 3 months of age.
Takeaways from the report note that:
- IVIB results in significant reduction in temperature compared
with placebo (in adults) and with acetaminophen (in pediatric
patients).
- Administration of the product prior to surgery leads to
patients waking up in significantly less postsurgical pain,
while also lessening or even eliminating the need for opioids.
- IVIB use in the hospital ED for acute pain can minimize opioid
requirements, while achieving pain control.
- IVIB is the only non-opioid injectable analgesic approved for
use in children as young as 3 months of age.
- IVIB should be considered a foundation for any multimodal pain
regimen.
"Pain management has become one of the most common health care
problems," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "As
this new report states, comprehensive multimodal pain regimens have
become key in preventing pain and optimizing pain control, while
minimizing the need for opioids. A non-steroidal anti-inflammatory
drug, or NSAID, such as Caldolor has become a cornerstone for many
treatment paradigms, and we are continually encouraged by the
growing database from our studies of the product in patients of all
ages."
To learn more about the clinical results demonstrated with IVIB
and read the full report at
https://www.pharmacypracticenews.com/Monographs-and-Whitepapers/Article/02-24/Intravenous-Ibuprofen-for-the-Treatment-of-Pain-and-Fever-An-Update/72896.
For full prescribing and safety information, visit
www.caldolor.com.
About Caldolor®
Caldolor is indicated in adults and pediatric patients for the
management of mild to moderate pain and the management of moderate
to severe pain as an adjunct to opioid analgesics, as well as 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 as well as
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. For full prescribing and safety
information, including boxed warning, visit www.caldolor.com.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is the largest
biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique
products that improve the quality of patient care. The company
develops, acquires, and commercializes products for the hospital
acute care, gastroenterology and oncology 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;
- Kristalose® (lactulose) oral, a
prescription laxative, for the treatment of constipation;
- Omeclamox®-Pak, (omeprazole,
clarithromycin, amoxicillin) oral, 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;
- Vaprisol® (conivaptan) injection,
to raise serum sodium levels in hospitalized patients with
euvolemic and hypervolemic hyponatremia; and
- 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.
The company also has a series of Phase II clinical programs
underway evaluating its ifetroban product candidate in patients
with cardiomyopathy associated with Duchenne Muscular Dystrophy,
Systemic Sclerosis and Idiopathic Pulmonary Fibrosis.
Investigational new study applications have been cleared by the FDA
enabling Cumberland to launch
clinical studies in each of these areas.
For more information on Cumberland's approved products, including full
prescribing information, please visit links to the individual
product websites, which can be found on the company's website at
www.cumberlandpharma.com.
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. Forward-looking
statements include, among other things, statements regarding the
company's intent, belief or expectations, and can be identified by
the use of terminology such as "may," "will," "expect," "believe,"
"intend," "plan," "estimate," "should," "seek," "anticipate," "look
forward" and other comparable terms or the negative thereof. 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 operation results. These factors
include macroeconomic conditions, including rising interest rates
and inflation, competition, an inability of manufacturers to
produce Cumberland's products on a
timely basis, failure of manufacturers to comply with regulations
applicable to pharmaceutical manufacturers, natural disasters,
public health epidemics, maintaining an effective sales and
marketing infrastructure, and other events beyond the company's
control as more fully discussed in its most recent annual report on
Form 10-K as filed with the U.S. Securities and Exchange Commission
(SEC), as well as the company's other filings with the SEC from
time to time. 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.