Gastrointestinal symptoms are commonly reported in as much as 65% of people with CF even independent of pancreatic enzyme replacement therapy (PERT) and the most frequent of these symptoms are bloating/distension, flatulence, abdominal pain and bowel habit changes. An alteration in the intestinal microbiome due to intestinal dysmotility, inflammation or other changes including pH changes in the intestine related to CFTR gene mutation may cause intestinal dysbiosis leading to a bacterial overgrowth in the proximal small intestine which may explain some of the findings of distension and bloating in CF.
Our small pilot study aims to investigate use of the only FDA-approved antibiotic, rifaximin for a GI syndrome- IBS, to treat bloating and global GI symptoms in CF patients with bloating and distension. Our goal is to recruit patients >12 years and age/sex matched into rifaximin and placebo arms with total of 100 recruited subjects recruited.

Start Date01 Feb 2025

Sponsor / Collaborator

Wake Forest School of Medicine

[+3]

NCT06718686 / Not yet recruitingPhase 1/2IIT

Rifaximin in Dementia Trial (RIDE): Gut-Brain Modulation with Rifaximin SSD in Dementia

Using a new formulation of rifaximin, a non-absorbable antibiotic, to test if it can affect microbes in the gut of patients with dementia favorably.

Start Date01 Dec 2024

Sponsor / Collaborator

Hunter Holmes McGuire VA Medical Center

[+1]

NCT06483737 / Not yet recruitingNot ApplicableIIT

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial

Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.

Start Date01 Oct 2024

Sponsor / Collaborator

The General Hospital of Shenyang Military Region

100 Clinical Results associated with Rifaximin

100 Translational Medicine associated with Rifaximin

100 Patents (Medical) associated with Rifaximin

1,638

Literatures (Medical) associated with Rifaximin

01 Jan 2025·CLINICAL IMMUNOLOGY

HLA evolutionary divergence effect on bacterial infection risk in cirrhotic liver transplant candidates

Article

Author: Taupin, Jean-Luc ; Lhotte, Romain ; Thabut, Dominique ; Conti, Filomena ; Roger, Clémentine ; Mazzola, Alessandra ; Mallet, Maxime

Bacterial infections are common in cirrhosis patients, increasing the risk of decompensation and death. The impact of HLA evolutionary divergence (HED) on infection risk hasn't been studied in humans before. We conducted a retrospective study on cirrhosis patients awaiting liver transplantation (LT) from January 2019 to February 2022, examining class I and II-HED effects on bacterial infections and cirrhosis decompensation. We included 269 cirrhosis patients. Among them, 98 experienced 153 bacterial infections. Multivariable analysis after variable selection revealed that higher class II-HED was linked to fewer bacterial infections (p = 0.034), while class I-HED showed no effect (p = 0.074). Independent risk factors for bacterial infections included invasive procedures (p < 0.001), ICU hospitalization (p < 0.001), recent antibiotic treatment (p = 0.046), rifaximin use (p = 0.043), and cirrhosis decompensation (p = 0.002). Neither class I nor II-HED affected decompensation risk. This pioneering study shows that high class II-HED levels may protect against bacterial infections in cirrhosis patients awaiting LT, suggesting an immunological mechanism at play.

31 Dec 2024·ANNALS OF MEDICINE

Rifaximin alleviates irinotecan-induced diarrhea in mice model

Article

Author: Chen, Jinggang ; Mao, Wei ; Xu, Shengkun ; Huang, Chengyi ; Zhu, Ji ; Chen, Qianping ; Lan, Huiyin ; Sun, Quanquan ; Bai, Minghua ; Jiang, Jin

BACKGROUND:

Irinotecan is a chemotherapeutic drug widely used to treat solid tumors. However, its effectiveness is limited by the severely delayed onset of diarrhea. This study aimed to confirm the protective effects of the non-systemic oral antibiotic rifaximin on irinotecan-induced mucositis in mice model.

MATERIALS AND METHODS:

Six to eight week-old BALB/c mice were treated with saline, irinotecan (50 mg/kg, i.p. once daily), rifaximin (50 mg/kg, p.o. twice daily), or irinotecan + rifaximin for 9 consecutive days. Signs of diarrhea, bloody diarrhea, and body weight were monitored daily. Intestinal tissues were harvested for histopathological analysis and quantitative PCR. SN38 and SN38G concentration in intestine were detected using LC-MS analysis. Intestinal bacteria β-glucuronidase (BGUS) activity was detected using mouse feces. We performed 16S rRNA sequencing to investigate the gut microbiota composition. Gut permeability was tested in vivo by measuring the fluorescein isothiocyanate-dextran intensity in the serum.

RESULTS:

Rifaximin reduced the frequency of delayed diarrhea and attenuated the severity of diarrhea caused by irinotecan in mice. Rifaximin significantly inhibited SN38 exposure in intestine and irinotecan-induced increase in BGUS activity. Rifaximin alleviated intestinal mucosal inflammation, prevented intestinal epithelial damage caused by irinotecan, and maintained gut barrier function. Moreover, the consecutive use of rifaximin did not cause a disorder in gut microbiota and reduced irinotecan-induced Firmicutes expansion. More importantly, rifaximin inhibited the expansion of some microbiota (such as Blautia, Eggerthella, and f_Enterobacteriaceae) and promoted an increase in beneficial microbiota (such as Lactobacillus intestinalis, Lachnospiraceae NK4A136 group, and f_Oscillospiraceae).

CONCLUSIONS:

Preventive use of rifaximin is a feasible method to protect against irinotecan-induced diarrhea.

01 Dec 2024·INTERNATIONAL IMMUNOPHARMACOLOGY

Rifaximin alleviates intestinal barrier disruption and systemic inflammation via the PXR/NFκB/MLCK pathway and modulates intestinal Lachnospiraceae abundance in heat-stroke mice

Article

Author: Du, Liwen ; Jiang, Wei ; Zhu, Xueqi ; Jiang, Weiqiang ; Fan, Youfen ; Zhu, Leilei

Heatstroke is a critical condition with a high mortality rate and intestinal barrier dysfunction is a key factor in its progression to sepsis in some patients. This study aimed to explore the protective effects of rifaximin on the intestinal barrier in heat-stroke mice and the underlying mechanisms. A mouse model of heat stroke was established, followed by rifaximin intervention. Rifaximin significantly improved survival rates, reduced core body temperature, and alleviated intestinal tissue damage. Further mechanistic studies revealed that rifaximin restored heat stroke-induced damage to intestinal barrier function by upregulating the expression of the tight junction proteins, ZO-1 and occludin. Additionally, 16S rRNA sequencing showed that rifaximin significantly increased the abundance of Lachnospiraceae in the gut and enhanced short-chain fatty acid butyrate levels. In vitro experiment results revealed that butyrate promotes the expression of the intestinal epithelial cell protein MUC2, thereby strengthening the intestinal barrier. Rifaximin also activated the pregnane X receptor (PXR) signaling pathway and inhibited the NF-κB/MLCK signaling pathway, reducing the permeability of intestinal epithelial cells. This study demonstrated that rifaximin protects the intestinal barrier in mice with heat stroke through multiple pathways by modulating the gut microbiota, increasing butyrate production, and activating the PXR signaling pathway. These findings provide a new theoretical basis for the clinical application of rifaximin in heat stroke treatment.

News (Medical) associated with Rifaximin

08 Nov 2024

·www.drugs.com

American College of Gastroenterology, Oct. 25-30

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.

Clinical Result

28 Oct 2024

·ir.bauschhealth.com

ACG Presidential Plenary to Highlight Analysis of Xifaxan® (rifaximin) Risk Reduction of Overt Hepatic Encephalopathy (OHE) Recurrence

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 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 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 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 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 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 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. 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® 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.

Drug Approval

01 Aug 2024

·ir.bauschhealth.com

Bausch Health Announces Second Quarter 2024 Results

Second quarter consolidated revenues of $2.40 billion, up 11% on a Reported and 8% on an Organic (non-GAAP)1 basis Consolidated GAAP Net Income Attributable to Bausch Health Companies Inc. of $10 million Consolidated Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $798 million, up 10% Raising consolidated full-year Revenue and Adjusted EBITDA (non-GAAP)1 guidance LAVAL, QC, August 1, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its second quarter 2024 financial results and other key updates from the quarter. "We continued our momentum in the second quarter, delivering our fifth consecutive quarter of year-over-year growth in revenues and adjusted EBITDA, underscoring the strength of our product and geographic footprint and reinforcing our strategy. We remain focused on advancing our R&D pipeline, strengthening our balance sheet and executing on our commercial strategies to drive growth globally. I'm proud of the hard work and accomplishments of our team, who work tirelessly to improve the health of patients worldwide," said Thomas J. Appio, Chief Executive Officer, Bausch Health. Second Quarter 2024 Revenue Performance Total consolidated reported revenues were $2.40 billion for the second quarter of 2024, compared with $2.17 billion in the second quarter of 2023, an increase of $236 million, or 11%. Excluding the impact of foreign exchange of $25 million, acquisitions of $104 million, and divestitures and discontinuations of $14 million, revenue increased by 8% organically1 compared with the second quarter of 2023. Reported revenues by segment were as follows: Three Months Ended June 30, Reported Change Change at Constant Currency1 (Non-GAAP) Change in Organic Revenue1 (Non-GAAP) (in millions) 2024 2023 Amount Pct. Total Bausch Health Revenues $2,403 $2,167 $236 11% 12% 8% Bausch Health (excl. B+L) $1,187 $1,132 $55 5% 5% 6% Salix segment $558 $557 $1 —% —% 1% International segment $276 $259 $17 7% 5% 6% Solta Medical segment $102 $88 $14 16% 19% 19% Diversified segment $251 $228 $23 10% 10% 12% Bausch + Lomb segment $1,216 $1,035 $181 17% 20% 10% Salix Segment Salix segment reported revenues were $558 million for the second quarter of 2024, compared with $557 million for the second quarter of 2023. Excluding the impact of divestitures and discontinuations of $5 million, segment revenues increased 1% on an organic1 basis. Xifaxan® revenues grew 10% compared with the second quarter of 2023, which was offset by declines in Relistor®, Trulance®, and certain non-promoted products. International Segment International segment reported revenues were $276 million for the second quarter of 2024, compared with $259 million for the second quarter of 2023, an increase of $17 million, or 7%. Excluding the impact of foreign exchange of $5 million and divestitures and discontinuations of $3 million, segment revenues increased organically1 by 6% compared with the second quarter of 2023, led by double-digit growth in Canada and solid growth in Latin America. Solta Medical Segment Solta Medical segment reported revenues were $102 million for the second quarter of 2024, compared with $88 million in the second quarter of 2023, an increase of $14 million, or 16%, which was driven by growth in Asia-Pacific, led by South Korea. Excluding the impact of foreign exchange of $3 million, segment revenues increased organically1 by 19% compared with the second quarter of 2023. Diversified Segment Diversified segment reported revenues were $251 million for the second quarter of 2024, compared with $228 million for the second quarter of 2023, an increase of $23 million, or 10%. Excluding the impact of divestitures and discontinuations of $4 million, segment revenues increased 12% on an organic1 basis, primarily attributable to increases in sales in Dermatology and Neurology. Bausch + Lomb Segment Bausch + Lomb segment reported revenues were $1,216 million for the second quarter of 2024, compared with $1,035 million for the second quarter of 2023, an increase of $181 million, or 17%. Excluding the impact of foreign exchange of $27 million, acquisitions of $104 million and divestitures and discontinuations of $2 million, the Bausch + Lomb segment revenues increased organically1 by 10% compared with the second quarter of 2023, driven by increases across all business units. 1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures and ratios to the most directly comparable GAAP measure. Read More View original release here: https://www.accesswire.com/viewarticle.aspx?id=894962

Financial StatementAcquisition

100 Deals associated with Rifaximin

External Link

KEGG	Wiki	ATC	Drug Bank
D02554	Rifaximin	D06AX11 A07AA11	DB01220

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Irritable bowel syndrome with diarrhea	US	Salix Pharmaceuticals, Inc.	27 May 2015
Turista	US	Salix Pharmaceuticals, Inc.	25 May 2004
Diarrhea	-	-	01 Jan 1985
Hepatic Encephalopathy	-	-	01 Jan 1985
Hyperammonemia	-	-	01 Jan 1985
Irritable Bowel Syndrome	-	-	01 Jan 1985

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diverticulitis	Phase 3	FR	Alfasigma SpA	27 Jun 2018
Diverticulitis	Phase 3	DE	Alfasigma SpA	27 Jun 2018
Diverticulitis	Phase 3	IT	Alfasigma SpA	27 Jun 2018
Diverticulitis	Phase 3	NL	Alfasigma SpA	27 Jun 2018
Diverticulitis	Phase 3	ES	Alfasigma SpA	27 Jun 2018
Diverticulitis	Phase 3	GB	Alfasigma SpA	27 Jun 2018
Ascites	Phase 3	FR	Alfasigma SpA	20 Mar 2018
Fibrosis	Phase 3	FR	Alfasigma SpA	20 Mar 2018
Spontaneous bacterial peritonitis	Phase 3	FR	Alfasigma SpA	20 Mar 2018
Crohn Disease	Phase 3	US	Bausch Health Americas, Inc.	21 Aug 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05098028 (CTgov)	Phase 2	Anemia, Sickle Cell	44	Low Dose Rifaximin ER (Low Dose Rifaximin ER)	gxqaisxres(ektikshczm) = kpfnujeibl mnimpjsutn (srrahgvgxs, alooprhmlc - faozdxarii) View more	-	19 Sep 2024
				High Dose Rifaximin ER (High Dose Rifaximin ER)	gxqaisxres(ektikshczm) = vztrxofdou mnimpjsutn (srrahgvgxs, hdiixddlbx - ampakyttch) View more
DDW2024	Not Applicable	Irritable Bowel Syndrome	-	Rifaximin 400 mg	ppqcoauxwp(qrrjdheoxc) = bqaygithnc naushvtjfj (vmehyjibrr ) View more	-	21 May 2024
PHASE II TRIAL OF RIFAXIMIN (DDW2024)	Phase 2	HER2 Positive Breast Cancer HER2 positive	20	Rifaximin 550 mg BID	nrzrivscrj(igwrdafidm) = pjokpimbzt acqgoexjyo (hgezporvgt ) View more	Positive	20 May 2024
DDW2024	Not Applicable	Blind Loop Syndrome	-	Berberine 400 mg	kukxxtkmit(qewoplcewo) = There was no significant difference in adverse events between BBR and RIF (12.0% vs. 9.52%, P=0.790) btatyygbft (ltfaygzscd )	-	20 May 2024
				Rifaximin 400 mg
DDW2024	Not Applicable	Blind Loop Syndrome	-	Rifaximin 400 mg t.i.d.	qjozepedwa(vnserwfxej) = vxnseyamuk ybbpwpzool (lypqagfftm ) View more	-	19 May 2024
NCT01345175 (CTgov)	Phase 3	Rectal Cancer	69	Rifaximin (Pts Receiving Rifaximin)	gjhphqkspu(sgurmrxzsw) = gxzocezeoc grfexmoheq (ezhvilxyci, wdidcdsxyk - shvmppgcjs) View more	-	14 May 2024
				Placebo (Pts Receiving Placebo)	gjhphqkspu(sgurmrxzsw) = npkukwxbbr grfexmoheq (ezhvilxyci, gmcngnalze - esmtojdfed) View more
NCT05150587 (CTgov)	Phase 2	Rosacea	216	Rifaximin (Rifaximin 250 mg TID)	lawlwmwqes(bwrsnoejqm) = czvwjjlxup hamhhffmcu (vnqgfshlmu, iyeuxkbqwi - uenufccozm) View more	-	24 Apr 2024
				Rifaximin (Rifaximin 500 mg TID)	lawlwmwqes(bwrsnoejqm) = xxhkogdrea hamhhffmcu (vnqgfshlmu, saeolzwccc - ojubuqawbz) View more
NCT01846663 (CTgov)	Phase 4	Hepatic Encephalopathy	6	Rifaximin (Rifaximin)	gavsmpepsy(lbvshxgeem) = egmkwdhytm wuvjcfnwyh (pcezsvksua, tvowammagc - lstpwdcuut) View more	-	09 Jan 2024
				Placebo (Placebo)	gavsmpepsy(lbvshxgeem) = twtedyufbn wuvjcfnwyh (pcezsvksua, screwqrvml - xflvcimhmv) View more
NCT03818672 (CTgov)	Phase 4	Liver Diseases	5	Rifaximin	lutgbwwotn(pyqjctresr) = qdjvuuisul iesubdaqxp (mfkmzudlxo, dczjzhauhr - qwwehftibu) View more	-	30 Nov 2023
GALA-RIF (AASLD2023)	Phase 3	Adrenoleukodystrophy	108	Rifaximin-	wrkryxqoba(plcxymfvjs) = ebmuhqrctz luwhtcuupz (nrmevkpfgf )	Positive	10 Nov 2023
				Placebo	wrkryxqoba(plcxymfvjs) = vsmcbngred luwhtcuupz (nrmevkpfgf )

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