budesonide rectal foam / Generic mfg. - LARVOL DELTA

Examination of the safety and effectiveness of budesonide rectal foam for patients with Ulcerative Colitis: Final report of post-marketing surveillance in Japan (ECCO-IBD 2025) - "The changes in VAS scores were significantly improved from baseline to week 2 (all p<0.0001 by t-test). Conclusion No new safety concerns were identified for the BF in Japanese patients with mild to moderate acute UC, and its effectiveness and improvements in health condition were confirmed in actual clinical practice."

Clinical • P4 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Novel desensitization therapy of mesalamine intolerance in patients with ulcerative colitis. (PubMed, Gastroenterol Hepatol) - "This retrospective study reports a successful and safe desensitization method for UC patients with mesalamine intolerance."

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

Survey on Patient Satisfaction with the Usability and Formulation of Budesonide Rectal Foam Following a Change in Head and Applicator Shape and Properties (PubMed, Yakugaku Zasshi) - "The change in packaging was thought to improve the usability of the formulation and patient satisfaction. The formulation's usability and ease of insertion had a clear influence on satisfaction with the rectal formulation."

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

Impact of twice-daily budesonide foam administration on early clinical response and endoscopic remission in patients with ulcerative colitis: a post hoc analysis. (PubMed, J Gastroenterol Hepatol) - "A BID budesonide administration regimen is preferred to increase the probability of early response and, following endoscopic remission, a better prognosis after stopping treatment."

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

Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study. (PubMed, Intest Res) - "The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed."

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

A Functional Medicine Program for Patients With Inflammatory Bowel Disease and Improvement in Fecal Calprotectin Levels (ACG 2023) - "Previous therapies included oral balsalazide, budesonide rectal foam, 6-mercaptopurine, methotrexate, adalimumab, infliximab, and vedolizumab. She achieved symptomatic improvement on tofacitinib, but serial colonoscopies showed persistent inflammation in the rectum and ascending colon...Previous therapy included mesalamine enemas...These cases show improvement in fecal calprotectin. A larger, prospective design with other measures of inflammation is needed to further investigate this effect."

Clinical • Crohn's disease • Fatigue • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Ulcerative Colitis

Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Bausch Health Americas, Inc.

New P4 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

PADAGIS ANNOUNCES FDA APPROVAL AND LAUNCH OF A-RATED GENERIC VERSION OF UCERIS (BUDESONIDE 2MG RECTAL FOAM) (PRNewswire) - "Padagis today announced the launch of Budesonide 2mg Rectal Foam (generic to Uceris®) with 180-days of Competitive Generic Therapy exclusivity....Uceris® is a prescription corticosteroid medicine used to help get active, mild to moderate ulcerative colitis that extends from the rectum to the sigmoid colon under control (induce remission)."

Generic launch • Inflammatory Bowel Disease • Ulcerative Colitis

Steroid-refractory gastrointestinal acute graft-versus-host disease treated with vedolizumab and ruxolitinib in a pediatric patient with therapy-related acute myeloid leukemia (PubMed, Rinsho Ketsueki) - "However, on day 49 post transplantation, she presented with diarrhea due to gastrointestinal acute graft-versus-host disease (aGVHD), and treatments with prednisolone, budesonide rectal foam, and human mesenchymal stem cells were ineffective. Thus far, only a few reports have been published regarding the administration of vedolizumab and ruxolitinib for steroid-refractory gastrointestinal aGVHD in children. Further evidence should be obtained from patients treated with vedolizumab and ruxolitinib to confirm their effectiveness for pediatric steroid-refractory gastrointestinal aGVHD."

Journal • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • CNS Tumor • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Neuroblastoma • Neuroendocrine Tumor • Oncology • Pediatrics • Solid Tumor • Transplantation

Expression of Concern: Middle-term prognosis in patients with ulcerative colitis who achieved clinical and endoscopic remission by budesonide rectal foam. (PubMed, PLoS One) - No abstract available

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

Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients (pts) with HER2+ early-stage breast cancer (eBC): the CONTROL trial (AACR 2017) - "Abstract embargoed at this time."

Clinical • Biosimilar • Breast Cancer • HER2 Breast Cancer • Oncology

Failed Tofacitinib Rescue Therapy in Acute Severe Ulcerative Colitis Refractory to Steroids and Anti-TNF Therapy (ACG 2022) - "Case Description/ A 60-year-old Indian man with a three-year history of ulcerative proctitis on mesalamine therapy was admitted to the hospital for diarrhea, abdominal pain, and hematochezia after failing outpatient oral prednisone and rectal budesonide foam...The patient was started on IV methylprednisolone 60 mg/daily...Due to the unavailability of inpatient Infliximab use in our hospital at the time, he was started on Adalimumab and received 160 mg dose, followed by another 160 mg injection in 9 days due to the lack of significant improvement after first dose...Clinicians should be cautious delaying a definitive surgical intervention until more robust data supports tofacitinib rescue therapy for this sick population. Fortunately, this patient had an uncomplicated post-op course and was discharged to rehab in ten days."

Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Bowel Disease • Pain • Ulcerative Colitis

A Case of Tinnitus in a Patient With Ulcerative Colitis on Rectal Mesalamine (ACG 2022) - "The patient was started on mesalamine enemas with subsequent improvement in bowel incontinence...To control his proctosigmoiditis, budesonide foam was used with a complete clinical response...Although this patient had normal liver function, his eGFR was reduced and he was on aspirin therapy for CAD, which may have increased his risk of developing tinnitus. It is important to recognize this potential complication of mesalamine, and assess these factors prior to prescribing mesalamine, counsel patients, and maintain close follow-up of patients with risk factors, as tinnitus is often easily reversible with mesalamine discontinuation. Further studies are needed to better understand the pharmacokinetics of rectal mesalamine and its role in systemic toxicity."

Clinical • Cardiovascular • Coronary Artery Disease • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hypertension • Immunology • Inflammatory Bowel Disease • Oncology • Otorhinolaryngology • Prostate Cancer • Renal Disease • Solid Tumor • Ulcerative Colitis

Bowel frequency (night) and urgent defecation are improved by budesonide foam in patients with ulcerative colitis: a retrospective observational study. (PubMed, BMC Gastroenterol) - "Budesonide foam administration significantly improves both bowel frequency (night) and urgent defecation-related UC activity and is also effective for the patients who were refractory to topical 5-ASA administration."

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

Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis, a Randomised, Controlled, Non-inferiority Trial. (PubMed, J Crohns Colitis) - P3 | "In patients with ulcerative proctitis, budesonide 4 mg suppository was non-inferior to budesonide 2 mg foam in efficacy, and both were safe and well tolerated. EudraCT no. 2016-001921-15."

Head-to-Head • Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Change of Marketing Scheme for "RECTABUL 2mg Rectal Foam 14 Doses" and AJM300 (Nonproprietary Name: Carotegrast Methyl), Both for Treatment of Ulcerative Colitis - Agreement Concluded (Kissei Press Release) - "EA Pharma Co., Ltd...and Kissei Pharmaceutical Co., Ltd...announced that the two companies signed an agreement to change the marketing scheme for their anti-ulcerative colitis products 'RECTABUL®2mg Rectal Foam 14 Doses' and AJM300 (nonproprietary name: carotegrast methyl), the latter is under marketing approval examination."

Licensing / partnership • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] STRICTURE FORMATION AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION OF SUPERFICIAL COLORECTAL LESIONS: A WESTERN SINGLE-CENTER EXPERIENCE (UEGW 2021) - "In rectal lesions with a mucosal defect ≥90%, budesonide rectal foam was administered for post-ESD stenosis prophylaxis... The incidence of stricture formation after colorectal ESD was low (1.02%) in a Western tertiary center and only patients who underwent circumferential or near-circumferential ESD of a rectal tumor developed this complication. Management of post-rectal ESD stenosis with endoscopic balloon dilation was effective and sufficient. Administration of topical steroids could be beneficial for prophylaxis of stricture formation only when rectal ESD leaves a mucosal defect ≥90% of the luminal circumference."

Clinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

[VIRTUAL] STRICTURE FORMATION AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION OF SUPERFICIAL COLORECTAL LESIONS: A WESTERN SINGLE-CENTER EXPERIENCE (UEGW 2021) - "In rectal lesions with a mucosal defect ≥90%, budesonide rectal foam was administered for post-ESD stenosis prophylaxis... The incidence of stricture formation after colorectal ESD was low (1.02%) in a Western tertiary center and only patients who underwent circumferential or near-circumferential ESD of a rectal tumor developed this complication. Management of post-rectal ESD stenosis with endoscopic balloon dilation was effective and sufficient. Administration of topical steroids could be beneficial for prophylaxis of stricture formation only when rectal ESD leaves a mucosal defect ≥90% of the luminal circumference."

Clinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

[VIRTUAL] STRICTURE FORMATION AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION OF SUPERFICIAL COLORECTAL LESIONS: A WESTERN SINGLE-CENTER EXPERIENCE (UEGW 2021) - "In rectal lesions with a mucosal defect ≥90%, budesonide rectal foam was administered for post-ESD stenosis prophylaxis... The incidence of stricture formation after colorectal ESD was low (1.02%) in a Western tertiary center and only patients who underwent circumferential or near-circumferential ESD of a rectal tumor developed this complication. Management of post-rectal ESD stenosis with endoscopic balloon dilation was effective and sufficient. Administration of topical steroids could be beneficial for prophylaxis of stricture formation only when rectal ESD leaves a mucosal defect ≥90% of the luminal circumference."

Clinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

[VIRTUAL] NOVEL BUDESONIDE SUPPOSITORY AND BUDESONIDE RECTAL FOAM INDUCE MUCOSAL HEALING IN ACUTE ULCERATIVE PROCTITIS (DDW 2021) - "BUS and BUF treatment were equivalent and highly effective in achieving CR and MH. BUS induced MH in the majority of patients. Patients clearly preferred the administration of BUS over BUF."

Inflammatory Bowel Disease

Real-world safety and efficacy of twice-daily budesonide 2-mg foam in patients with ulcerative colitis: interim analysis of post-marketing surveillance. (PubMed, Expert Opin Pharmacother) - "At week 6, 72.6% (77/106) of the patients reported as 'good compliance' and 54.7% (58/106) of the patients as 'very easy' for administration, using a self-administered questionnaire. Budesonide foam appeared to be safe, efficacious, and well-accepted in a real-world cohort of patients with UC. Trial registration: JapicCTI-183858."

Clinical • Journal • P4 data • Real-world evidence • Acne Vulgaris • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

An update on the treatment of IgA nephropathy. (PubMed) - Curr Opin Nephrol Hypertens - "Until less toxic therapies for IgAN are available, treatment with corticosteroids will need to be made in the context of conflicting evidence, and should likely be limited to patients at highest risk of disease progression who understand the significant risk of adverse events."

Journal • Biosimilar • Renal Disease

An online educational portal improves concerns of inflammatory bowel disease patients regarding pregnancy and medication (ECCO-IBD 2017) - "Medication history: 10 (12.8%) sulfasalazine, 67 (85.9%) mesalamine/5-ASAs, 17 (21.8%) budesonide, 63 (80.8%) steroids, 12 (15.4%) methotrexate, 55 (70.5%) azathioprine/mercaptopurine, 42 (53.8%) biologics, and 38 (48.7%) antibiotics. Our educational web portal reduces the proportion of patients who report certain concerns about pregnancy in IBD, in addition to concerns regarding their IBD medications."

Clinical • Biosimilar • Crohn's disease • Immunology • Inflammatory Bowel Disease

Phenotypes in autoimmune hepatitis in Australia (AGW 2016) - "(2) Non-standard therapies: 14 had non-standard therapy (7 received budesonide, 4 mycophenolate, 5 methotrexate, 1 cyclosporine, and 8 had ursodeoxycholic acid). Two others had inflammatory bowel disease: one on cyclosporine (also had psoriasis), and one on adalimumab, maintained without steroid or AZA. (5) DI-AIH: Only one patient had DI-AIH, which was precipitated by infliximab. A significant number of patients remain dependent on moderate to high doses of steroids. Most patients with cirrhosis have a benign course."

Retrospective data • Biosimilar • Cardiovascular • Fibrosis • Immunology • Inflammatory Bowel Disease • Psoriasis

Salix Announces early termination of HSR waiting period for pending transaction (Salix Press Release) - "Salix...announced that it has received notice of the early termination of the waiting period for U.S. antitrust review...Completion of the transaction remains subject to approval by Salix’s stockholders and certain other closing conditions."

Anticipated M & A • Inflammatory Bowel Disease