Caldolor® is the only
injectable non-opioid approved for treating pain in infants
NASHVILLE, Tenn., 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 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.
Full prescribing and safety information can be found at the
brand's website www.caldolor.com.
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.
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.