budesonide ER / Generic mfg. - LARVOL DELTA

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P4 | N=70 | Recruiting | Sponsor: Bausch Health Americas, Inc. | Trial completion date: Dec 2024 ➔ Jun 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

A real-world, observational study comparing the side effects of budesonide MMX with prednisolone and the resolution of symptoms in patients with mild to moderate ulcerative colitis (ECCO-IBD 2025) - "Some prednisolone-related side effects were not reported following treatment with budesonide MMX. Of those that were, only 1 patient reported that they affected daily life, indicating that budesonide MMX may have a lower impact on patients’ daily activities.Either rectal bleeding or stool frequency was resolved in over three quarters of patients by week 4 of flare therapy with budesonide MMX."

Adverse events • Clinical • Observational data • Real-world • Real-world evidence • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CMV infection in IBD patients with disease flare in the era of advanced therapies and outpatient setting (ECCO-IBD 2025) - "Median CRP was 27,5 mg/L (range 3-240), all patients had normal leucocytes and thrombocytes count and no liver tests abnormalities.None of the patients had systemic corticosteroids at the time of CMV diagnosis, one patient was using topical budesonide and one budesonide-MMX; three patients were treated with infliximab for several years; two had vedolizumab; one ustekinumab and two patients had no treatment and were about to start their first line biologic.All patients were treated with virostatic treatment with valganciclovir or ganciclovir.All patients had their biologic treatment interrupted for the time of antivirotic treatment. Conclusion CMV infection in IBD patients with active colonic disease is rare but when present, it can lead to systemic manifestation of the infection. In contrast to the thus far reported typical picture of infection complicating severe ulcerative colitis, it can occurs in both, Crohn’s disease and ulcerative colitis patients with moderate..."

Clinical • Metastases • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

Insights from the Polish Registry of Microscopic Colitis. The Overlapping Symptoms of Microscopic Colitis and Irritable Bowel Syndrome. (ECCO-IBD 2025) - "The most effective treatment was budesonide MMX, with a 93.2% improvement rate. 54% of patients using rifaximin and almost 40% of patients using probiotics reported improvement in intestinal symptoms, although these are not recommended therapies in MC...Five patients with severe MC were successfully treated with biologics (three with adalimumab and two with vedolizumab)...The overlap in symptoms, necessitate a comprehensive clinical evaluation to select appropriate treatment and avoid unnecessary escalation of immunosuppressive therapy. The much more frequent diagnosis of the lymphocytic subtype than the collagenous subtype indicates the need for discussion with pathologists about the potential underdiagnosis of collagenous colitis in Poland."

Immunology • Inflammatory Bowel Disease

Budesonide MMX for prevention of colonic stricture after subcircumferential endoscopic submucosal dissection. (PubMed, Gastrointest Endosc) - No abstract available

Journal

CORTICOSTEROID-SPARING EFFECT OF MIRIKIZUMAB FOR THE TREATMENT OF MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS: EXTENDED INDUCTION SUBGROUP ANALYSIS FROM PHASE 3 TRIAL (UEGW 2024) - P3 | "Patients receiving mirikizumab on CS at baseline (n=351) remained on their stable baseline dose (prednisone ≤20 mg/day or equivalent, budesonide MMX 9 mg/day, or beclomethasone 5 mg/day) during induction (W0 to W12). Nearly 70% of extended induction responders discontinued CS by W52. CS-sparing effect of mirikizumab in patients with moderately-to-severely active UC is clinically meaningful and aligns with the treatment goal of CS discontinuation."

P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

INSIGHTS FROM THE POLISH REGISTRY OF MICROSCOPIC COLITIS: ANALYSIS OF THE FIRST 165 PATIENTS ACROSS NINE ACADEMIC GASTROENTEROLOGY REFERENCE CENTERS IN POLAND (UEGW 2024) - "Three patients with severe MC were successfully treated with adalimumab.Number of patients using treatmentNumber of patients reporting improvement after treatmentNumber of patients reporting no improvement after treatmentImprovement after treatment (in percentage)Budesonide MMX9285792.4%Budesonide2321291.3%Loperamide34151944.1%Mesalazine1851327.8%Rifaximine40202050.0%Probiotics45153033.3%Table 1. The Polish Registry of Microscopic Colitis provides comprehensive insights into the clinical features and treatment outcomes of MC in Poland. Budesonide MMX emerged as an effective treatment option, while biologic therapy showed promise in refractory cases. Our findings suggest a potential overlap of symptoms between MC and IBS, highlighting the importance of thorough clinical assessment."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Novel Coronavirus Disease • Pain

Practical management of mild-to-moderate ulcerative colitis: an international expert consensus. (PubMed, Expert Rev Gastroenterol Hepatol) - "Furthermore, noninvasive tools for patient monitoring such as fecal calprotectin and intestinal ultrasound are now available. Their implementation in clinical practice will allow clinicians to tightly monitor disease activity and promptly adapt treatment, avoiding complications and disease progression and targeting better disease control."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Bausch Health, Canada Inc. Announces Additional Public Drug Plan Listings for PrUCERIS(R) (Budesonide) Aerosol Foam To Treat Mild to Moderate Distal Ulcerative Colitis in Adults (Yahoo Finance) - "Bausch Health, Canada Inc...today announced additional Canadian public drug plan listings for Pr UCERIS (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults. UCERIS has most recently become available for patients through the public drug plans of Alberta, Prince Edward Island and Newfoundland and Labrador, as well as to beneficiaries of the federal drug plans for Indigenous people through the Non-Insured Health Benefit (NIHB) and Veterans Affairs Canada."

Reimbursement • Inflammatory Bowel Disease • Ulcerative Colitis

Drug Optimization in Patients with Mild-to-Moderate Ulcerative Colitis: A Global Survey. (PubMed, J Clin Med) - "Budesonide MMX (41.8%) and systemic steroids (39.9%) were preferred in patients who failed 5-ASA...Endoscopic remission remains the main therapeutic target, followed by clinical remission. Fecal calprotectin and intestinal ultrasound still elicit complaints from physicians."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

WARNING TO DELAY IN DIAGNOSING MICROSCOPIC COLITIS IN OLDER ADULTS. A SERIES OF CASES. (PubMed, Arq Gastroenterol) - "Older females using high-risk medications are suggestive of MC. Preventing delay in the diagnosis of MC is crucial to improvement in patients´ quality of life. Budesonide MMX appears to be effective, safe and well-tolerated."

Journal • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Corticosteroid-sparing effect of mirikizumab for the treatment of moderately-to-severely active Ulcerative Colitis: Extended induction subgroup analysis from Phase 3 trial (ECCO-IBD 2024) - P3 | "Patients receiving mirikizumab on CS at baseline (n=351) remained on their stable baseline dose (prednisone ≤20 mg/day or equivalent, budesonide MMX 9 mg/day, or beclomethasone 5 mg/day) during induction (W0 to W12). Conclusion Nearly 70% of extended induction responders discontinued CS by W52. CS-sparing effect of mirikizumab in patients with moderately-to-severely active UC is clinically meaningful and aligns with the treatment goal of CS discontinuation."

P3 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Management and treatment optimization of patients with mild to moderate ulcerative colitis. (PubMed, Expert Rev Clin Immunol) - "Realizing individualized plans through informed shared-decision making between health-care providers and fully engaged patients holds promise to maximize quality of life outcomes. Continuous improvement relies on innovation bridging different domains to overcome current limitations and push the field toward more predictive and tailored care."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: University of Calgary | Initiation date: Sep 2023 ➔ Jan 2024

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology

Treatment of Patients with Mild to Moderate Ulcerative Colitis: A Middle East Expert Consensus. (PubMed, J Clin Med) - "We conducted an expert consensus to standardize the management of patients with mild to moderate UC. Sixteen experts in inflammatory bowel diseases, through a well-established and accepted Delphi methodology, voted and approved eight statements in order to provide practical guidance to clinicians in the Middle East."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Corticosteroid Use Among Patients With Crohn’s Disease and Ulcerative Colitis on Advanced Therapy From the CorEvitas Inflammatory Bowel Disease Registry (ACG 2023) - "bSystemic steroids include budesonide/Entocort EC, budesonide extended release/Uceris MMX, prednisone, other... A total of 1351 pts with CD (active disease: 370, remission: 981) and 894 pts with UC (active disease: 333, remission: 561) were evaluated ( Table ). For CD and UC, 28.9% and 36.6% of pts with active disease and 18.1% and 21.8% of pts in remission had systemic CS use, respectively. Demographic and other patient characteristics were generally similar, as >50% of the study population were white females."

Clinical • Metastases • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P4 | N=70 | Recruiting | Sponsor: Bausch Health Americas, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

New Bausch Health Treatment PrUCERIS(R) (budesonide) Aerosol Foam Now Available Across Canada to Treat Mild to Moderate Distal Ulcerative Colitis in Adults (Yahoo Finance) - "Bausch Health Companies Inc...is pleased to announce that following its approval by Health Canada the new treatment UCERIS; (budesonide) aerosol foam is now available across Canada to treat mild to moderate distal ulcerative colitis in adults."

Launch Canada • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and safety of oral beclomethasone dipropionate and budesonide MMX versus 5-aminosalicylates or placebo in ulcerative colitis: a systematic review and meta-analysis. (PubMed, Therap Adv Gastroenterol) - "No differences were found between 5-ASA and BDP or budesonide MMX. Surely, more RCTs, also comparing BDP and budesonide MMX, are mandatory to confirm or not these results."

Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Assessment of the effectiveness of Budesonide MMX for active, mild-to-moderate ulcerative colitis in the Polish sub-group of the CORE Practice prospective multi-centre observational study. (PubMed, Prz Gastroenterol) - "Budesonide MMX was safe and well tolerated. The therapy was satisfactory for patients and showed a beneficial effect on the patients' quality of life."

Journal • Observational data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

COSMO ANNOUNCES CORTIMENT APPROVAL IN JAPAN (Cosmo Press Release) - "Cosmo Pharmaceuticals N.V...announced that its partner Ferring Pharmaceuticals ('Ferring') has received the approval for Cortiment® (budesonide 9 mg MMX tablets) in Japan by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). First sales of Cortiment® in Japan are expected to begin by end of Q3 2023."

Japanese regulatory • Launch Japan • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: University of Calgary

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology

"Can Uceris alone induce remission for distal colitis?" (@htownoilcount)

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology

Possible genetical predictors of efficacy and safety of budesonide-MMX in patients with mild-to-moderate ulcerative colitis, and safety comparison with methylprednisolone. (PubMed, Expert Opin Drug Saf) - "CYP genotypes can affect the efficacy of budesonide-MMX; however, further studies would be needed with analyses of gene expression. Although budesonide-MMX is safer than methylprednisolone, due to glucocorticoid-related side effects, admission should require greater precaution."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CYP3A4 • CYP3A5

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P4 | N=70 | Not yet recruiting | Sponsor: Bausch Health Americas, Inc. | Trial completion date: Jun 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis