Megacolon, Toxic

Strategic decisions enable Bracco to serve better the needs of healthcare providers and patients with its enhanced pipeline offering MONROE TOWNSHIP, N.J., July 8, 2024 /PRNewswire/ -- Bracco Diagnostics Inc. (BDI), the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, is pleased to provide an update on its barium product portfolio as part of a comprehensive rationalization process. Bracco Diagnostics Inc. launched an initiative with its barium portfolio to invest in new and expanded product offerings driven by customer and patient demand. In addition, the company is pursuing FDA approval for its fourth product and expects to file for approval later this year. Upon anticipated approval, BDI will offer an enhanced line of FDA-approved barium products for abdominal imaging needs. "We remain committed to advancing the barium and oral imaging field," said Cosimo De Pinto, Senior Vice President of Sales and Marketing at BDI. "Our ongoing investment in new and expanded product offerings reflects our dedication to supporting healthcare providers in delivering exceptional patient care." At the same time, market changes and evolving procedural changes have led BDI to discontinue three of its non-FDA-approved barium products due to a significant decline in product usage. BDI does not anticipate discontinuing any additional barium products. "We understand the importance of providing high-quality diagnostic imaging solutions to our customers," continued Cosimo De Pinto. "Our rationalization process was essential to ensure that our resources are allocated effectively to meet the evolving needs of the medical community." As part of its commitment to innovation, BDI is excited to unveil its pipeline, providing a glimpse of its upcoming product launches over the next 24 months: Q3 2024: CitraClear™, a gutsy filling beverage, designed to enhance patient satisfaction during preparation for imaging procedures. Q4 2024: VARIBAR® (barium sulfate) "Mini" packaging, offering convenient and sustainable packaging options for healthcare facilities. 2025: Introduction of a new flavor in our CT barium line, further enhancing the patient experience during imaging examinations. BDI invites healthcare providers and industry partners to explore its barium pipeline and looks forward to continuing to collaborate in advancing diagnostic imaging technologies. INDICATIONS for VARIBAR® (barium sulfate) VARIBAR® THIN HONEY (barium sulfate) oral suspension, VARIBAR® NECTAR (barium sulfate) oral suspension, and VARIBAR® THIN LIQUID (barium sulfate) oral suspension are radiographic contrast agents indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR® HONEY (barium sulfate) oral suspension and VARIBAR® PUDDING (barium sulfate) oral paste are radiographic contrast agents indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients with known or suspected perforation of the gastrointestinal (GI) tract; known obstruction of the GI tract; high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis; high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation; known severe hypersensitivity to barium sulfate or any of the excipients of the product used. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Barium sulfate preparations contain a number of excipients, including natural and artificial flavors, and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy, food allergies, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction. Intra-abdominal Barium Leakage The use of VARIBAR PRODUCTS is contraindicated in patients at high risk of perforation of the GI tract. Administration of VARIBAR PRODUCTS may result in leakage of barium from the GI tract in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation. Delayed Gastrointestinal Transit and Obstruction Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure. When administering VARIBAR PUDDING, consider the administration of laxatives. Aspiration Pneumonitis The use of VARIBAR PRODUCTS is contraindicated in patients with trachea-esophageal fistula. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. In patients at risk for aspiration, begin the procedure with a small ingested volume of VARIBAR PRODUCTS. Monitor the patient closely for aspiration, discontinue administration of VARIBAR PRODUCTS if aspiration is suspected, and monitor for development of aspiration pneumonitis. Systemic Embolization Barium sulfate products may occasionally intravasate into the venous drainage of the GI tract and enter the circulation as a "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate. ADVERSE REACTIONS The most common adverse reactions are nausea, vomiting, diarrhea, and abdominal cramping. Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for full Prescribing Information for VARIBAR® THIN LIQUID (barium sulfate) oral suspension. Please click here for full Prescribing Information for VARIBAR® THIN HONEY (barium sulfate) oral suspension. Please click here for full Prescribing Information for VARIBAR® NECTAR (barium sulfate) oral suspension. Please click here for full Prescribing Information for VARIBAR® HONEY (barium sulfate) oral suspension. Please click here for full Prescribing Information for VARIBAR® PUDDING (barium sulfate) oral paste. VARIBAR is manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 08831. VARIBAR is a registered trademark of E-Z-EM, Inc. For additional information about Bracco's products, and for full prescribing information, please visit . About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom, and the United States. Bracco Group global revenues were 1.4 billion Euros in 2020. To learn more about Bracco Imaging, Bracco Diagnostics Inc. Media Relations (USA) Kimberly Gerweck Senior Manager, Marketing Communications [email protected] D: +1 609-524-2777 SOURCE Bracco Group

The antibiotic vancomycin, recommended as first-line treatment for infection caused by the deadly superbug C. difficile (C. diff), may not be living up to its promise, according to new research. The antibiotic vancomycin, recommended as first-line treatment for infection caused by the deadly superbug C. difficile (C. diff), may not be living up to its promise, according to new research from the University of Houston College of Pharmacy. C. diff infection is the leading cause of death due to gastroenteritis in the U.S. It causes gastrointestinal symptoms ranging from diarrhea and abdominal pain to toxic megacolon, sepsis and death. Based on 2018 clinical practice guidelines, the use of oral vancomycin has increased by 54% in the past six years, but the clinical cure rates have decreased from nearly 100% in the early 2000's to around 70% in contemporary clinical trials. "Despite the increasing prevalence of data showing reduced effectiveness of vancomycin, there is a significant lack of understanding regarding whether antimicrobial resistance to these strains may affect the clinical response to vancomycin therapy," reports Anne J. Gonzales-Luna, research assistant professor in the Department of Pharmacy Practice and Translational Research, UH College of Pharmacy, in the journal Clinical Infectious Diseases. "In fact, the prevailing view has been that antibiotic resistance to these strains are unlikely to impact clinical outcomes, given the high concentrations of vancomycin in stools." But the team arrived at a different conclusion after sifting through research included in a multicenter study, which included adults treated with oral vancomycin between 2016-2021 for C. diff infection. "We found reduced vancomycin susceptibility in C. difficile was associated with lower 30-day sustained clinical response and lower 14-day initial cure rates in the studied patient cohort," said Gonzales-Luna. The finding is cause for concern. "It's an alarming development in the field of C. diff as there are only two recommended antibiotics," said Kevin Garey, professor of pharmacy practice and translational research. "If antimicrobial resistance increases in both antibiotics, it will complicate the management of C. diff infection leading us back to a pre-antibiotic era." Others on the research team include Taryn A. Eubank from UH and Chetna Dureja and Julian G Hurdle from Texas A&M Health Science Center in Houston.

SUFLAVE™ offers the same efficacy as SUPREP® Bowel Prep Kit BRAINTREE, Mass., June 22, 2023 /PRNewswire/ -- Sebela Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) granted approval of SUFLAVE™ (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), for colonoscopy preparation in adults. SUFLAVE, a low-volume, safe and effective colonoscopy preparation – with a taste similar to a lemon-lime sports drink – was developed and will be marketed by Braintree Laboratories, a leader in gastroenterology and part of Sebela Pharmaceuticals. The current active screening rate in the United States for colorectal cancer (CRC) is 72%, leaving 28% unscreened, which contributes to 153,000 CRC diagnoses and more than 52,000 deaths annually.i,ii Colonoscopy is the most common detection method for colorectal cancer, a leading cause of cancer-related deaths that can be managed more effectively through screening and early detection.iii Successful colonoscopy screening is dependent upon adequate cleansing of the colon.iv Despite this, available methods of liquid preparation are not widely accepted by patients due to large volumes of poor-tasting solutions, resulting in low patient compliance and the need for repeat screenings. Additionally, colonoscopy preparation products and processes are commonly cited as a significant patient barrier to colon cancer screening,v reinforcing an unmet need among patients for better bowel preparation options. Tolerance of bowel preparation remains the largest deterrent for patients considering screening colonoscopy with 71% of patients saying it's the worst part of colonoscopy and 55% indicating it was the greatest deterrent to a future colonoscopy.vi Prep volume, palatability and patient education are three key factors in reducing prep hesitancy. "Patients frequently struggle with the taste and volume of traditional bowel preparations – and fear related to the preparation can also negatively impact patient willingness to undergo follow-up colonoscopy if it is indicated," said Douglas K. Rex, M.D., Distinguished Professor Emeritus at Indiana University School of Medicine and a full time practicing clinical gastroenterologist. "I believe the palatable lemon-lime flavor of SUFLAVE will be a welcomed option for patients – reducing preparation hesitancy and giving more people the chance to feel comfortable during preparation and getting a successful and effective procedure." In a head-to-head pivotal study versus SUPREP® Bowel Prep Kit, (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Solution, 94% of patients achieved successful bowel cleansing with SUFLAVE. The majority of patients reported that SUFLAVE tastes like a sports drink, and 79% of patients found the taste neutral to very pleasant compared to SUPREP (54%). Additionally, 87% of patients found SUFLAVE tolerable to very easy to consume, and 80% of patients reported that they would ask for SUFLAVE for a subsequent colonoscopy. Rates of gastrointestinal adverse events with SUFLAVE were low (<8%).vii "We believe in patient choice and are committed to improving the colon preparation process for patients. We are delighted with the FDA's approval of SUFLAVE – which has efficacy equivalent to SUPREP, but with taste similar to a sports drink," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "We are proud of the hard work and dedication of the Braintree team and the phase 3 trials investigator group who continue to bring new, better choices to people undergoing colonoscopy screening." SUFLAVE is the latest innovation in colonoscopy preparation from Braintree Laboratories. In November 2020, the FDA approved the company's tablet preparation, SUTAB®, which has had an excellent adoption record with use by over 2 million patients. SUFLAVE will be available by prescription to patients in the U.S. in early August. IMPORTANT SAFETY INFORMATION SUFLAVE™ (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINISTRATION: A low residue breakfast may be consumed on the day before colonoscopy, followed by clear liquids up to 2 hours prior to colonoscopy. Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion. Each bottle and one flavor-enhancing packet are equivalent to one dose. An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: Gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredient in SUFLAVE. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration; Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. ADVERSE REACTIONS: Most common adverse reactions (> 2%) are: nausea, abdominal distension, vomiting, abdominal pain, and headache. DRUG INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance. See Full Prescribing Information and Medication Guide About Sebela Pharmaceuticals Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development including Tegoprazan which is in phase 3 trials for gastro-esophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). In addition, Sebela Women's Health has two next generation intra-uterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth. Please visit sebelapharma.com for more information or call 800-874-6756. Forward-looking Statements This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of SUFLAVE™; growth and opportunity, including peak sales and the potential demand for SUFLAVE™, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Sebela Pharmaceuticals does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. For further information, contact: Logan Campbell, Red Havas [email protected] 1-724-987-2781 ______________ i Centers for Disease Control and Prevention. (2023, March 22). Colorectal (colon) cancer statistics. Center for Disease Control and Prevention. Retrieved June 12, 2023, from ii Colorectal cancer – statistics. Cancer.net (2023, February). Retrieved June 12, 2023, from iii Doubeni CA, Corley DA, Quinn VP, et al. Effectiveness of screening colonoscopy in reducing the risk of death from right and left colon cancer: a large community-based study. Gut. 2018;67(2):291-298 iv Harrison, N. M., & Hjelkrem, M. C. (2016). Bowel cleansing before colonoscopy: Balancing efficacy, safety, cost and patient tolerance. World journal of gastrointestinal endoscopy, 8(1), 4–12. v Romero, R. V., & Mahadeva, S. (2013). Factors influencing quality of bowel preparation for colonoscopy. World journal of gastrointestinal endoscopy, 5(2), 39–46. vi emulapalli KC, Lahr RE, Rex DK. 2021 Patient Perceptions Regarding Colonoscopy Experience. J Clin Gastroenterol. 2023 Apr 1;57(4):400-403. doi: 10.1097/MCG.0000000000001689. PMID: 35324481. vii Data on File, Braintree, MA: Braintree Laboratories, Inc. SOURCE Sebela Pharmaceuticals