ACG Presidential Plenary to Highlight Analysis of Xifaxan(R) (rifaximin) Risk Reduction of Overt Hepatic Encephalopathy (OHE) Recurrence
Bausch Health announced upcoming presentations at the American College of Gastroenterology 2024 Annual Scientific Meeting, featuring key analyses of Xifaxan and Plenvu. The main highlight is a Presidential Plenary presentation comparing Xifaxan monotherapy to lactulose monotherapy in reducing overt hepatic encephalopathy (OHE) recurrence and mortality. Additional research includes data on Xifaxan's impact on OHE rehospitalizations in commercial and Medicare patients, and Plenvu's efficacy as a bowel preparation medication in patients with comorbid conditions or taking medications affecting bowel prep quality.
Bausch Health ha annunciato le prossime presentazioni al Meeting Scientifico Annuale del Collegio Americano di Gastroenterologia 2024, presentando analisi chiave di Xifaxan e Plenvu. Il punto culminante è una presentazione plenaria presidenziale che confronta la monoterapia con Xifaxan con la monoterapia con lattulosio nella riduzione della ricorrenza e della mortalità dell'encefalopatia epatica overt (OHE). Ulteriori ricerche includono dati sull'impatto di Xifaxan sulle readmissioni per OHE in pazienti commerciali e Medicare, e l'efficacia di Plenvu come medicinale per la preparazione intestinale in pazienti con condizioni comorbili o che assumono farmaci che influenzano la qualità della preparazione intestinale.
Bausch Health anunció próximas presentaciones en la Reunión Científica Anual del Colegio Americano de Gastroenterología 2024, que incluirán análisis clave de Xifaxan y Plenvu. El aspecto más destacado es una presentación plenaria presidencial que compara la monoterapia con Xifaxan con la monoterapia con lactulosa en la reducción de la recurrencia y la mortalidad de la encefalopatía hepática franca (OHE). La investigación adicional incluye datos sobre el impacto de Xifaxan en las readmisiones por OHE en pacientes comerciales y de Medicare, y la eficacia de Plenvu como medicamento para la preparación intestinal en pacientes con condiciones comórbidas o que toman medicamentos que afectan la calidad de la preparación intestinal.
바우쉬 헬스는 2024년 미국 소화기학회 연례 과학 회의에서 Xifaxan 및 Plenvu에 대한 주요 분석을 발표할 예정이라고 발표했습니다. 주요 하이라이트는 Xifaxan 단독 요법과 락툴로스 단독 요법이 명백한 간성 뇌병증(OHE)의 재발 및 사망률을 줄이는 비교를 포함하는 대통령 전원회의 발표입니다. 추가 연구는 상업 환자 및 메디케어 환자에서 OHE 재입원에 대한 Xifaxan의 영향과 동반 질환이 있거나 장 준비 품질에 영향을 미치는 약물을 복용하는 환자에서 Plenvu의 장 준비 약물로서의 효능을 포함합니다.
Bausch Health a annoncé de prochaines présentations lors de la Réunion Scientifique Annuelle du Collège Américain de Gastroentérologie 2024, présentant des analyses clés de Xifaxan et Plenvu. Le point d'orgue est une présentation plénière présidentielle comparant la monothérapie avec Xifaxan à la monothérapie avec lactulose pour réduire la récidive et la mortalité de l'encéphalopathie hépatique manifeste (OHE). Des recherches supplémentaires incluent des données sur l'impact de Xifaxan sur les réadmissions pour OHE chez les patients commerciaux et Medicare, ainsi que l'efficacité de Plenvu en tant que médicament de préparation intestinale chez les patients souffrant de comorbidités ou prenant des médicaments affectant la qualité de la préparation intestinale.
Bausch Health kündigte bevorstehende Präsentationen auf dem Jahreskongress der American College of Gastroenterology 2024 an, die wichtige Analysen zu Xifaxan und Plenvu vorstellen. Der Hauptfokus liegt auf einer präsidialen Plenarsitzung, die die Monotherapie mit Xifaxan mit der Monotherapie mit Laktulose im Hinblick auf die Verringerung der Rückfälle und der Sterblichkeit bei manifeste hepatische Enzephalopathie (OHE) vergleicht. Weitere Forschungen umfassen Daten zu den Auswirkungen von Xifaxan auf OHE-Wiederaufnahmen bei kommerziellen und Medicare-Patienten sowie die Wirksamkeit von Plenvu als Medikament zur Darmvorbereitung bei Patienten mit komorbiden Erkrankungen oder bei der Einnahme von Medikamenten, die die Qualität der Darmvorbereitung beeinflussen.
- Xifaxan monotherapy data selected for prestigious Presidential Plenary Session presentation
- Research expansion into multiple patient populations (commercial and Medicare)
- None.
Insights
This upcoming conference presentation appears to be a routine scientific update without immediate financial implications. While the research on Xifaxan's efficacy compared to lactulose monotherapy is scientifically interesting, it's a post hoc analysis of existing trial data rather than new clinical trial results. The presentations on rehospitalization rates and Plenvu efficacy are observational studies that, while valuable for clinical practice, are unlikely to significantly impact near-term business performance or stock value.
These types of academic presentations typically serve to reinforce existing market positions rather than drive new revenue streams. For Bausch Health investors, while the continued research support for Xifaxan is positive for maintaining market position, this news doesn't represent a material catalyst that would significantly affect the company's financial outlook or stock performance.
Additional ACG presentation to focus on impact of Xifaxan on OHE rehospitalizations
LAVAL, QC / ACCESSWIRE / October 27, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), announced that results of an analysis of Xifaxan® (rifaximin) monotherapy will be presented during a Presidential Plenary Session of The American College of Gastroenterology® 2024 Annual Scientific Meeting taking place October 25-30 in Philadelphia, PA. This post hoc analysis of data from two randomized trials evaluated the efficacy of Xifaxan monotherapy compared to lactulose monotherapy for risk reduction of overt hepatic encephalopathy (OHE) recurrence and all-cause mortality.
During ACG, Salix will also present new data on the impact of Xifaxan use on rehospitalizations following an OHE hospitalization discharge in both commercially insured and Medicare patient populations.
Two posters to be presented at the ACG meeting will also share findings for Plenvu® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) as a bowel preparation medication, including efficacy findings from colonoscopy patients who have either comorbid conditions or are taking concomitant medications that are known to impact bowel prep quality.
"These presentations at ACG 2024 can give healthcare professionals confidence that treatments from Salix have potential to improve outcomes for their patients" said Aimee Lenar, Executive Vice President, US Pharma at Bausch Health. "Bausch Health remains dedicated to pursuing life-changing solutions and continues to invest in expanding the body of evidence for our medicines today and in the future."
The complete list of Salix research and analyses to be presented at ACG 2024 is as follows:
XIFAXAN
Bajaj, Jasmohan S. et.al. Rifaximin Monotherapy Is More Effective Than Lactulose Monotherapy for Reducing the Risk of Overt Hepatic Encephalopathy (OHE) Recurrence and All-Cause Mortality: An Analysis of Two Randomized Trials
Presidential Plenary Session 2; Presentation #9
Monday, October 28, 10:06 - 10:18 AM ET
Jesudian, Arun B. et.al. Impact of Rifaximin Use on Overt Hepatic Encephalopathy (OHE) Rehospitalizations Post Discharge from an OHE Hospitalization in Commercially and Medicare Insured Patients
Poster #P1162
Sunday, October 27, 3:30 PM - 7:00 PM ET
PLENVU
Cash, Brooks D. et.al. Efficacy and Safety of the 1 Liter NER1006 Bowel Preparation for Colonoscopy in Adults With Comorbid Conditions That May Impact Prep Quality
Poster #P3667
Tuesday, October 29, 10:30 AM - 4:00 PM ET
Poppers, David. et.al. One-Liter NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients Taking Concomitant Medications Known to Impact Prep Quality
Poster #P3657
Tuesday, October 29, 10:30 AM - 4:00 PM ET
About XIFAXAN
INDICATION
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were:
HE (≥
10% ): Peripheral edema (17% ), constipation (16% ), nausea (15% ), fatigue (14% ), insomnia (14% ), ascites (13% ), dizziness (13% ), urinary tract infection (12% ), anemia (10% ), and pruritus (10% )IBS-D (≥
2% ): Nausea (3% ), ALT increased (2% )INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.
About PLENVU
INDICATION
PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) is a prescription medication used by adults to clean the colon before a colonoscopy.
IMPORTANT SAFETY INFORMATION
Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU®.
PLENVU® and other bowel preparations can cause serious side effects including loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause abnormal heartbeats that may result in death, seizures (even if you have never had a seizure), or kidney problems. Your chance of having fluid loss and changes in body salts with PLENVU® is higher if you have heart problems, kidney problems, or take water pills, high blood pressure medicine, or non-steroidal anti-inflammatory drugs (NSAIDS).
Your healthcare provider may do blood tests after you take PLENVU® to check your blood for changes. Tell your healthcare provider right away if you have any symptoms of too much fluid loss (dehydration) including vomiting, dizziness, heart problems, kidney problems, seizures, dry mouth, urinating less often than normal; headache, or feel faint, weak, or lightheaded, especially when you stand up.
PLENVU® can cause ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.
PLENVU® can cause serious allergic reactions that may include skin rash, itching, raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat; and kidney problems.
The most common side effects in patients taking PLENVU® were nausea, vomiting, dehydration, and stomach pain or discomfort.
Tell your healthcare provider about all of your medical conditions and medicines you take, including prescription, nonprescription medicines, vitamins, and herbal supplements before you take PLENVU®
These are not all the possible side effects of PLENVU®. Ask your healthcare provider for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
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SOURCE: Salix Pharmaceuticals
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FAQ
What will be presented about Xifaxan (BHC) at ACG 2024?
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What studies about Plenvu will BHC present at ACG 2024?
