- New Dosing Regimen Simplifies
Administration -
NASHVILLE, Tenn., Dec. 9, 2024
/PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq:
CPIX), a specialty pharmaceutical company focused on delivering
high-quality products to improve patient care, announced today the
FDA has approved a supplemental New Drug Application (sNDA) for its
Acetadote® (N-acetylcysteine for injection) product.
Acetadote is an intravenous (IV) formulation of N-acetylcysteine
(NAC) indicated to prevent or lessen liver injury after ingestion
of potentially toxic quantities of acetaminophen1.
Acetaminophen, a common over-the-counter pain reliever and fever
reducer, is the leading cause of acute liver failure in
the United States. Each year,
thousands of individuals experience accidental or intentional
acetaminophen poisoning, leading to serious liver damage.
The newly approved dosing regimen simplifies the administration
of Acetadote by combining the first two bags of the standard
regimen into a single, slower infusion. This streamlined approach
has been implemented in hospitals across multiple countries and
demonstrated to reduce the frequency of medication errors and
potentially serious non-allergic anaphylactoid reactions (NAARs)
without compromising the effectiveness of Acetadote2-6.
By simplifying the dosing regimen, health care providers can
administer the life-saving treatment more efficiently, potentially
improving patient outcomes.
"This FDA approval is a significant step forward in the
treatment of acetaminophen overdose," said Rick Dart, MD, PhD, Director at the Rocky
Mountain Poison and Drug Center. "By streamlining the
administration of NAC, we can improve patient outcomes and reduce
the risk of adverse events. This simplified dosing regimen is a
valuable tool for health care providers in managing this
potentially life-threatening condition."
"We are thrilled to announce the FDA approval of this simplified
dosing regimen for Acetadote," said A.J. Kazimi, Cumberland's Chief Executive Officer. "This
important milestone underscores our commitment to improving patient
care and providing innovative solutions for urgent medical needs.
By streamlining the administration process, we aim to enhance
patient outcomes and reduce the burden on health care
providers."
Key Highlights:
- FDA-approved sNDA adds a simplified, IV NAC dosing regimen to
the product prescribing information.
- New IV NAC dosing regimen is both safe and effective.
- New dosing regimen aims to minimize interruptions in care,
medication errors and incidence of dose-related reactions.
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 the individual product
websites, which can be found on the company's website
www.cumberlandpharma.com.
References:
- Acetadote [Package Insert]. Nashville, TN: Cumberland Pharmaceuticals,
Inc.; 2024.
- O'Callaghan C, Graudins A, Wong A. A two-bag acetylcysteine
regimen is associated with shorter delays and interruptions in the
treatment of paracetamol overdose. Clin Toxicol (Phila). 2022
Mar;60(3):319-323.
- Sudanagunta S, Camarena-Michel A, Pennington S, et al.
Comparison of Two-Bag Versus Three-Bag N-Acetylcysteine Regimens
for Pediatric Acetaminophen Toxicity. Ann Pharmacother. 2023
Jan;57(1):36-43.
- Syafira N, Graudins A, Yarema M, et al. Comparing development
of liver injury using the two versus three bag acetylcysteine
regimen despite early treatment in paracetamol overdose. Clin
Toxicol (Phila). 2022 Apr;60(4):478-485.
- Wong A, Isbister G, McNulty R, Isoardi K, Harris K, Chiew A,
Greene S, Gunja N, Buckley N, Page C, Graudins A. Efficacy of a two
bag acetylcysteine regimen to treat paracetamol overdose (2NAC
study). EClinicalMedicine. 2020 Mar 19;20:100288
- Cole JB, Oakland CL, Lee SC,
et al. Is two better than three? A systematic review of two-bag
intravenous NAC regimens for acetaminophen poisoning. West J Emerg
Med. 2023 Sep;24(6)
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.