–
Real World Study Compared Over 150,000 Adult & Pediatric
Patients –
–
Caldolor Associated with Fewer Adverse Drug Reactions
–
– Caldolor
also Improved Healthcare Utilization –
NASHVILLE, Tenn., Nov. 5, 2024
/PRNewswire/ -- Specialty pharmaceutical company Cumberland
Pharmaceuticals (Nasdaq: CPIX) today announced the publication of
new real-world outcomes research demonstrating the safety and
healthcare resource advantages of its Caldolor (ibuprofen)
injection over ketorolac in both adult and pediatric populations.
The study, published in Frontiers of Pain Research, provides
compelling evidence that Caldolor is associated with a
significantly reduced incidence of adverse drug reactions (ADRs)
and improved healthcare utilizations when compared to
ketorolac.
This extensive, retrospective, payer database analysis evaluated
the records of over 17 million patients who had received either
ketorolac or Caldolor. Ultimately, 31,046 Caldolor and 124,184
ketorolac adult patients were selected and compared for ADRs and
subsequent healthcare resource utilization, which includes
inpatient, outpatient and emergency department visits as well as
all procedures and prescriptions during the follow up time of 29
days. An additional 5,579 pediatric patients were identified in
each arm and compared in a separate claims analysis.
Key findings reveal that, in adults, Caldolor was associated
with a 45% reduction in renal dysfunction (p<0.001) and a 78%
decrease in hematuria rates (p<0.001) when compared to
ketorolac. Notably, patients also experienced fewer
gastrointestinal complications as well as reduced headaches, nausea
and abdominal pain. Among pediatric patients, the results showed
Caldolor was associated with a 51-65% lower rate of ADRs, including
headache and nausea, with 95% confidence intervals supporting
clinical significance.
Caldolor also demonstrated a positive impact on healthcare
resource utilization (HCRU) when compared to ketorolac, with
decreased emergency room and outpatient visits, as well as a
shortened hospital length of stay for both adults and children.
"These findings underscore Caldolor's potential to improve
patient care by reducing their treatment complications, while also
delivering potential savings for healthcare systems through
decreased hospital readmissions and shortened treatment times,"
said A.J. Kazimi, CEO of Cumberland Pharmaceuticals.
About Caldolor® (ibuprofen) Injection
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 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. 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;
- 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.
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
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. 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.