– New dosing regimen simplifies management –
Nashville, Tennessee., December 9, 2024 /PRNewswire/ — Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX)A specialty pharmaceutical company focused on delivering high-quality products to improve patient care, announced today that the FDA has approved a supplemental new drug application (sNDA) for acetadote.® (N-acetylcysteine for injection) products. Acetadote is an intravenous (IV) formulation of N-acetylcysteine (NAC) that has been shown to prevent or reduce liver damage after ingesting potentially toxic amounts of acetaminophen.1.
Acetaminophen, a common over-the-counter painkiller and antipyretic, is a major cause of acute liver failure. US. Each year, thousands of people experience accidental or intentional acetaminophen poisoning, resulting in severe liver damage.
The newly approved dosing regimen simplifies administration of acetadote by combining the first two bags of the standard dosing regimen into one slow infusion. This streamlined approach, which has been implemented in hospitals in multiple countries, reduces the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions (NAARs) without compromising the effectiveness of acetadote. has been proven.2-6. By simplifying dosing regimens, healthcare providers can deliver life-saving treatments more efficiently and potentially improve patient outcomes.
“This FDA approval is an important step forward in the treatment of acetaminophen overdose.” rick dartMD, Director, Rocky Mountain Poison and Drug Center. “Streamlining the administration of NAC can improve patient outcomes and reduce the risk of adverse events. This simplified dosing regimen will help healthcare providers manage this potentially life-threatening condition.” It’s a valuable tool.”
“We are very pleased to announce FDA approval of this simplified dosing regimen for acetadote,” said AJ Kazimi. cumberland’s chief executive officer. “This important milestone underscores our commitment to improving patient care and providing innovative solutions to urgent medical needs. By streamlining administrative processes, we are improving patient outcomes. , we aim to reduce the burden on healthcare providers.”
Main highlights:
- The FDA-approved sNDA adds a simplified IV NAC dosing regimen to the product prescribing information.
- The new IV NAC dosing regimen is safe and effective.
- The new dosing regimen aims to minimize treatment interruptions, medication errors, and the occurrence of dose-related reactions.
About Cumberland Pharmaceuticals
Cumberland Pharmaceutical Co., Ltd. is the largest biopharmaceutical company founded and headquartered in . tennessee We are 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.
- Kaldor® (ibuprofen) Injections for the treatment of pain and fever.
- crystal rose® (Lactulose) An oral, prescription laxative for the treatment of constipation.
- Sanxo® (Granisetron) for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy.
- Vaprisol® (conivaptan) Injection to increase serum sodium concentration in hospitalized patients with normohemia and hypervolemic hyponatremia. and
- vibative® (Telavancin) injection. It is used to treat certain serious bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complex skin and skin structure infections.
The company also has a series of ongoing Phase II clinical programs evaluating ifetroban product candidates in patients with cardiomyopathy associated with Duchenne muscular dystrophy, systemic sclerosis, and idiopathic pulmonary fibrosis.
For more information, cumberland’s For approved products, including complete prescribing information, please visit the individual product websites on the Company’s website. www.cumberlandpharma.com.
References:
- acetadote [Package Insert]. Nashville, Tennessee: Cumberland Pharmaceutical Co., Ltd.; 2024.
- O’Callaghan C, Graudins A, Wong A. Two-bag acetylcysteine therapy is associated with fewer delays and interruptions in the treatment of paracetamol overdose. Clintoxycol (Fila). 2022 Mar;60(3):319-323.
- Sudanagunta S, Camarena-Michel A, Pennington S, et al. Comparison of N-acetylcysteine 2-bag and 3-bag regimens for pediatric acetaminophen toxicity. Ann Pharmacist. 2023 Jan;57(1):36-43.
- Syafira N, Graudins A, Yarema M, et al. To compare the progression of liver injury using acetylcysteine 2-bag and 3-bag regimens despite early treatment in paracetamol overdose. Clintoxycol (Fila). 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 against paracetamol overdose (2NAC study). EC clinical medicine. 2020 March 19;20:100288
- Cole JB, Oakland CL; Lee SCet al. Is two better than three? A systematic review of two-bag intravenous NAC regimens for acetaminophen poisoning. West J Emerg Med. September 24, 2023 (6)
Forward-looking statements
This press release contains forward-looking statements that involve and reflect certain risks. cumberland’s We represent our current views about future events based on reasonable assumptions. There is no guarantee that these events will occur. Forward-looking statements include, among other things, statements regarding the Company’s intentions, beliefs or expectations, such as “may”, “will”, “expect”, “believe”, “intend”, etc. can be identified by the use of terminology. “‘plan,’ ‘estimate,’ ‘should,’ ‘seek,’ ‘anticipate,’ ‘forward-looking,’ and other comparable terms or the negative thereof.” Like any other business, at every stage, cumberland’s Our operations are affected by factors outside of our control, and any one or a combination of these factors may have a material effect on us. cumberland’s Operation result. These factors include macroeconomic conditions such as rising interest rates and inflation, competition, and reduced manufacturing capacity. cumberland’s As detailed in our most recent annual report, the timely compliance of products, failure by pharmaceutical companies to comply with regulations applicable to them, natural disasters, public health epidemics, effective marketing and maintenance of marketing infrastructure and other events beyond the Company’s control. Filed on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) and other filings we make from time to time with the SEC. There can be no guarantee that the company’s anticipated results will be achieved or that the expected benefits will be achieved. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. We undertake no obligation to publicly revise these statements to reflect events after the date of this document.
SOURCE Cumberland Pharmaceuticals, Inc.
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