Lactulose

- 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: 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-approves-acetadote-snda-302326652.html SOURCE Cumberland Pharmaceuticals Inc. Investor Contact: Shayla Simpson, Cumberland Pharmaceuticals, (615) 255-0068; Media Contact: Molly Aggas, Dalton Agency, (704) 641-6641

The annual meeting of the American College of Gastroenterology was held from Oct. 25 to 30 in Philadelphia and attracted participants from around the world, including gastroenterology and digestive disease specialists and other health care professionals. The conference featured presentations focusing on clinical updates in gastroenterology and hepatology as well as the latest advances in digestive health and gastrointestinal disorders. In one study, Khaled Alsabbagh Alchirazi, M.D., of Aurora Healthcare in Brookfield, Wisconsin, and colleagues found that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are not associated with an increased risk for pancreatic cancer among patients with type 2 diabetes mellitus (T2DM). The authors evaluated the association between GLP-1 RAs and pancreatic cancer risk among T2DM patients. Deidentified electronic health records (EHRs) were used to identify patients with T2DM who were prescribed antidiabetic medications between 2005 and 2020 and had no prior antidiabetic drug use and no prior diagnosis of pancreatic cancer. The researchers compared GLP-1 RAs to other antidiabetic medications and found that T2DM patients on GLP-1 RAs did not have an increased incidence of pancreatic cancer. "Clinicians could consider GLP-1 RAs as a viable option for diabetes treatment, guiding more confident decision-making in long-term diabetes care," Alchirazi said. One author disclosed ties to Boston Scientific and Cook Endoscopy. Abstract No. 52 In another study, Temi Olasehinde, M.D., of Case Western Reserve University in Cleveland, and colleagues found that GLP-1 RAs may serve as protective agents against early-onset colorectal cancer (EO-CRC), which is relevant given the disease's rising incidence and mortality worldwide. The authors evaluated the impact of the use of GLP-1 RAs on EO-CRC among patients with T2DM. A retrospective cohort study was performed using data from deidentified EHRs. The researchers found that GLP-1 RA use was associated with a significantly decreased risk for EO-CRC development in patients with T2DM with or without obesity. "Our findings will need to be validated further in prospective studies," Olasehinde said. "However, it does show the potential for this agent to be used as a protective agent against EO-CRC, thereby adding to the growing body of research looking at preventative/risk-tailored strategies to decrease the risk of EO-CRC in this population." Abstract No. P2134 Jacqueline Khalil, D.O., of Case Western Reserve University/Metro Health in Beachwood, Ohio, and colleagues identified an association between hormone replacement therapy and an increased risk for developing irritable bowel syndrome (IBS), a risk that persisted over time. A population-based cohort study was performed using data from deidentified EHRs for postmenopausal women aged 50 years or older, with and without a prescription for hormone replacement therapy. The researchers found that hormone replacement therapy was associated with a higher risk for developing IBS. In addition, hormone replacement therapy correlated with elevated gastrointestinal symptoms, including abdominal distention and flatulence, increased medication utilization (particularly with medications prescribed to patients with IBS), and increased diagnostic testing. "These findings emphasize the importance of considering the potential consequences of hormone replacement therapy in postmenopausal women, particularly regarding IBS," Khalil said. "Clinicians should be cognizant about the gastrointestinal impact and effects when prescribing hormone replacement therapy." One author disclosed ties to Allurion, Bristol Myers Squibb, Johnson & Johnson, and Vibrant. Abstract No. P2357 Jasmohan S. Bajaj, M.D., of the Virginia Commonwealth University School of Medicine in Richmond, and colleagues found that rifaximin monotherapy is associated with a significantly lower rate of overt hepatic encephalopathy (OHE) recurrence and mortality among individuals with cirrhosis. The authors performed a post-hoc analysis of two randomized clinical trials involving patients with prior OHE. Specifically, they compared lactulose monotherapy and rifaximin monotherapy to each other; major outcomes were OHE recurrence, HE-related hospitalizations, and mortality at six months. The comparisons included cohorts of more than 280 patients across multiple centers worldwide. The researchers found that rifaximin monotherapy was tied to a lower rate of OHE recurrence and mortality. In addition, compared with the patients on rifaximin monotherapy, a greater proportion of patients on lactulose monotherapy had drug discontinuation due to diarrhea and other gastrointestinal-related adverse effects. "If confirmed, this could encourage the use of rifaximin alone rather than with lactulose therapy for prevention of HE recurrence and potentially a mortality benefit," Bajaj said. Several authors disclosed ties to pharmaceutical companies, including Salix Pharmaceuticals, which manufactures rifaximin. Abstract No. 9 ACG: GLP-1 RAs Tied to Lower Risk for Early-Onset Colorectal Cancer FRIDAY, Nov. 1, 2024 -- Glucagon-like peptide-1 receptor agonists can decrease the risk for developing early-onset colorectal cancer in patients with diabetes regardless of weight, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text ACG: 2000 to 2022 Saw Rise in Early-Onset CRC Mortality in the United States THURSDAY, Oct. 31, 2024 -- Early-onset colorectal cancer mortality rose in the United States over the past two decades, most notably in patients aged 20 to 44 years, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text ACG: Hormone Therapy Tied to Higher Risk for New Irritable Bowel Syndrome THURSDAY, Oct. 31, 2024 -- Hormone replacement therapy is associated with an increased risk for developing irritable bowel syndrome in postmenopausal women, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text ACG: Fewer Overt Hepatic Encephalopathy Episodes Seen With Rifaximin MONDAY, Oct. 28, 2024 -- For patients with a history of overt hepatic encephalopathy, rifaximin monotherapy results in significantly fewer overt hepatic encephalopathy episodes than lactulose monotherapy, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.