FDA APPROVES ACETADOTE® sNDA
CPIX 12.09.2024
About Gravity Analytica
-New Dosing Regimen Simplifies Administration -
Acetaminophen, a common over-the-counter pain reliever and fever reducer, is the leading cause of acute liver failure in
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
"We are thrilled to announce the FDA approval of this simplified dosing regimen for Acetadote," said
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
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 websitewww.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
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SOURCE
Investor Contact: Shayla Simpson, Cumberland Pharmaceuticals, (615) 255-0068; Media Contact: Molly Aggas, Dalton Agency, (704) 641-6641