Symproic (naldemedine) / Shionogi, Collegium Pharma - LARVOL DELTA

SAFETY AND EFFECTIVENESS OF NALDEMEDINE TOSILATE FOR OPIOID-INDUCED CONSTIPATION IN PATIENTS AGED ≥75 YEARS WITH NON-CANCER CHRONIC PAIN: A POST-MARKETING SURVEILLANCE STUDY IN JAPAN (UEGW 2026) - "Full abstract will be published on the day of presentation"

Clinical • Late-breaking abstract • P4 data • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

PROPHYLACTIC NALDEMEDINE FOR OPIOID-INDUCED NAUSEA AND VOMITING IN PATIENTS WITH CANCER INITIATING OPIOID THERAPY: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL (POSEIDON) (UEGW 2026) - P4 | "Prophylactic naldemedine significantly improved complete response and reduced patient-reported nausea and vomiting compared with placebo in patients with cancer initiating opioid therapy, with a favorable safety profile. These findings support the use of naldemedine as a prophylactic strategy for OINV at the time of opioid initiation."

Clinical • Constipation • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Musculoskeletal Diseases • Oncology • Solid Tumor

Diagnosis and Treatment Gaps in Opioid-Induced Constipation: A National Real-World Analysis Using the Epic Cosmos EHR Network (ACG 2026) - "Adults â¥18 years with chronic opioid exposure (â¥3 prescription orders spanning â¥90 days; hydrocodone, oxycodone, morphine, fentanyl, tramadol, or methadone) were included...During 12 months of follow-up, we assessed formal OIC diagnosis (K59.03), laxative prescriptions, PAMORA prescriptions (methylnaltrexone, naloxegol, naldemedine), and constipation-related ED visits or hospitalizations (K59.0x, K56.41)... Among chronic opioid users, 40.73% received laxatives, while only 8.81% had a formal OIC diagnosis, representing a >4-fold gap between treatment and documented coding. PAMORA prescribing was 13.97%, exceeding formal diagnosis rates and suggesting targeted therapy may occur despite absent structured OIC coding. Constipation-related complications increased with age (18â44: 0.48%; â¥85: 1.37%), whereas PAMORA prescribing was lowest in patients â¥85 years (11.57%) despite higher complication burden."

Clinical • Real-world • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder

Taiwan Expert Guidance for the Diagnosis and Management of Opioid-Induced Constipation. (PubMed, Asian J Anesthesiol) - "Peripherally acting μ-opioid receptor antagonists, of which naldemedine is currently the available agent in Taiwan, are preferred for laxative-refractory OIC and may be used alone or in combination with laxatives. Persistent symptoms should prompt consideration of opioid adjustment and further evaluation. A practical algorithm is proposed to harmonize OIC recognition, coding, and treatment escalation in Taiwan while remaining adaptable to individual patient needs."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Integrated bioinformatics and molecular docking identify novel key genes, pathways, and potential candidate drugs in papillary thyroid carcinoma. (PubMed, J Genet Eng Biotechnol) - "According to docking analysis, Olysio, Gabapentin, Naldemedine, Imatinib and Enzacamene were drugs that exhibited strong interactions with the target proteins. The findings of the current study offer that FN1, DPP4, CD36, KIT, ITGA2 and hsa-miR-124-3p may be novel biosignatures and therapeutic targets for PTC. In addition, it was demonstrated that discovered pharmaceuticals may be employed as prospective PTC treatments."

Journal • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma • CD36 • ITGA2 • MIR124-2 • MIR124-3 • SCARB1

Preventive effect of naldemedine for opioid-induced constipation in patients with cancer starting opioids: A multicenter, double-blinded, randomized, placebo-controlled, phase 3 trial. (ASCO 2024) - "Naldemedine is a valuable option with proven efficacy in preventing OIC in cancer patients starting regular strong opioids."

Clinical • Late-breaking abstract • P3 data • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

Naldemedine for Opioid-Induced Constipation in Patients With Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial. (PubMed, J Clin Oncol) - "Naldemedine prevented constipation and improved constipation-related QOL, with possible preventive effect on OINV in patients with cancer starting regularly dosed opioids therapy."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

Single-cell analysis of the synovium and infrapatellar fat pad identifies key pathogenic genes and drug targets in osteoarthritis. (PubMed, Int J Clin Exp Pathol) - "This study identified the key cell populations driving OA progression in the synovium and IFP, and screened four novel diagnostic biomarkers and three potential drug targets for OA, with their expression verified in an in vitro OA model. Lumacaftor and naldemedine were found to have multi-target binding activity to OA core drug targets. These findings deepen the understanding of OA's molecular mechanisms mediated by the synovium and IFP, and provide valuable experimental evidence for OA's early diagnosis and the development of targeted therapeutic drugs, including old drug repurposing."

Journal • Immunology • Metabolic Disorders • Osteoarthritis • Pain • Rheumatology • IL15 • IR • PTGDS

Naldemedine Initiation Timing after Oxycodone Start and Early Laxative Adjustment in Cancer Care: A Retrospective Cohort Study. (PubMed, Palliat Med Rep) - "Concurrent naldemedine at oxycodone start did not eliminate early additional laxative initiation or escalation. Naldemedine timing should be understood within individualized bowel-management planning, with conventional or rescue laxatives considered when clinically appropriate."

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain • Palliative care

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Shionogi | Trial completion date: Jun 2026 ➔ Jun 2028 | Trial primary completion date: Jun 2026 ➔ Jun 2028

Trial completion date • Trial primary completion date • Constipation • Gastroenterology • Gastrointestinal Disorder • Pediatrics

Multicentre, double-blind, randomised, placebo-controlled study on the prophylactic use of naldemedine for opioid-induced nausea and vomiting in patients with cancer (POSEIDON study): a protocol paper. (PubMed, BMJ Open) - P4 | "The results of the study will be presented at academic conferences in Japan or overseas and submitted for publication in a peer-reviewed journal. NCT07038551 and jRCTs031250128."

Clinical protocol • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain • Palliative care • Preventive care

M2 macrophage activation in recurrent acute pancreatitis: an explorative analysis of a randomized controlled trial. (PubMed, Scand J Gastroenterol) - "Naldemedine did not significantly affect M2 macrophage activation, suggesting limited immunomodulatory effects. However, changes in sCD163 plasma levels correlated with clinical disease activity, highlighting macrophage activation in RAP."

Journal • Pain • Pancreatitis • MRC1

A Pilot Real-life Study Opioid Induced Constipation in Neoplastic Patients Admitted to Internal Medicine Ward. Outcome of Naldemedine Therapy According to Available Guidelines. (PubMed, J Gastrointestin Liver Dis) - "The prevalence of opioid use and OIC is relevant among hospitalized cancer patients. The systematic adoption of standardized diagnostic tools can improve recognition and the clinical management in patients with OIC, in particular in case of refractory OIC. It is essential to increase awareness on this condition and to implement management pathways based on existing guidelines."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

CHRONIC KIDNEY DISEASE AND ACUPUNCTURE: AN UNEXPECTED TURNAROUND (ERA 2026) - "The patient was able to discontinue all home medications (sodium bicarbonate, ebastine, pantoprazole, famotidine, macrogol, treoli, rizmoic, trimebutine, pyridostigmine, rifaximin/VSL, normast, bisacodyl, glycerin, senna, buprenorphine) retaining only clonazepam. Why this case is exeptional In summary, this case demonstrates that acupuncture may provide meaningful clinical benefits in patients with CKD who experience refractory symptoms, supporting its consideration as a complementary approach in nephrology care. Table Laboratory Parameters and Medications Changes in a patient treated with Acupuncture Baseline (March 2025) Session VII (July 2025) Follow-up (Jan 2026) sCreat (mg/dL) 2.19 1.68 1.96 Urea (mg/dL) 74 64 79 eGFR (mL/min) 25 35 28 Total sProtein (g/dL) 7.3 7.1 6.9 Uprot (mg/day) 675 693 800 UUrea (g/die) 10 14.4 13.2 Hb (g/dL) 13.4 13.6 13.1 HCO3 (mmol/L) 21 28 21 Total N. Medications 16 1 3 Image TE6 point needling for treating constipation"

Cardiovascular • Chronic Kidney Disease • Constipation • Endometriosis • Gastroenterology • Gastrointestinal Disorder • Gynecology • Inflammation • Metabolic Disorders • Movement Disorders • Musculoskeletal Pain • Nephrology • Renal Disease

Multi-Target Inhibition of F10/F2/PAR1 Through In Silico Drug Repurposing of Avodart and Naldemedine to Prevent Thrombotic-Induced Sudden Cardiac Arrest. (PubMed, Biomedicines) - "Compared to the other two drugs (Digoxin and Ledipasvir), Avodart and Naldemedine showed high affinity, higher adherence to drug likeness, lower metabolic inhibition risks and lack of acute toxicity, and were therefore the most suitable candidates. The study proposes Avodart and Naldemedine as promising candidates for drug repurposing in antithrombotic therapy. This study provides a computational blueprint for the development of next-generation, broad-spectrum anticoagulants."

Journal • Cardiovascular • Thrombosis

Peripherally Acting Mu-Opioid Receptor Antagonist Use in Opioid-Induced Constipation in Patients With Cancer: A Scoping Review. (PubMed, Clin J Oncol Nurs) - "Most adverse effects were gastrointestinal in nature but were generally mild to moderate in severity. Naloxegol and naldemedine were shown to be effective for long-term OIC management, and methylnaltrexone was effective for short-term relief."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

Examination of Factors Affecting the Efficacy of Naldemedine Tosilate Tablets for Opioid-Induced Constipation (PubMed, Gan To Kagaku Ryoho) - "Pre-NAL constipation (Grade 2 or higher) was a significant factor associated with an odds ratio of 4.383 (p = 0.009). However, caution should be exercised regarding the onset of diarrhea and watery stool formation after NAL administration."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study (clinicaltrials.gov) - P4 | N=120 | Completed | Sponsor: International University of Health and Welfare | Recruiting ➔ Completed | Trial completion date: Sep 2027 ➔ Feb 2026

Trial completion • Trial completion date • Oncology

Current Strategies and Future Perspectives in the Management of Opioid-Induced Constipation: A Review of International and Japanese Guidelines. (PubMed, Neurogastroenterol Motil) - "The 2023 Japanese guidelines advocate the proactive use of the PAMORA naldemedine as a primary treatment option. This mechanism-based early intervention model offers a promising framework for optimizing QoL and implementing effective analgesia in an aging global population."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

Cost-Effectiveness of Prophylactic Naldemedine for Opioid-Induced Constipation in Patients with Cancer. (PubMed, J Palliat Med) - "This is the first global cost-effectiveness analysis of prophylactic naldemedine in patients with cancer. Prophylactic naldemedine for opioid-induced constipation in patients with cancer initiating strong opioid therapy could be justifiable as an efficient use of finite health care resources."

HEOR • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology

German Expert Consensus on Opioid-Induced Constipation (OIC): Recommendations and a Treatment Algorithm for Clinical Practice. (PubMed, J Clin Med) - "In Europe, the PAMORAs methylnaltrexone, naloxegol and naldemedine are approved for the treatment of OIC. This consensus paper provides both evidence-based and practice-oriented recommendations for the systematic management of OIC. By promoting patient education, early recognition, structured evaluation and stepwise treatment escalation, the presented statements and algorithm aim to improve patient outcomes and quality of life under opioid therapy including better adherence to opioid therapy."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain • Palliative care

Comparison of Diarrhea Incidence Following Initial Naldemedine Administration in Patients Receiving Strong Opioids: A Retrospective Cohort Study. (PubMed, J Pain Palliat Care Pharmacother) - "Thirty-nine patients were included (morphine, 1; oxycodone, 27; fentanyl, 5; hydromorphone, 6). Exploratory analyses suggested that fentanyl use and female sex were associated with diarrhea incidence, although estimates were imprecise. Early post-naldemedine diarrhea incidence was common but uniformly mild, with a higher incidence among fentanyl recipients, but these hypothesis-generating findings require validation in larger prospective studies."

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology

Dose-dependent association of naldemedine and magnesium oxide in the management of opioid-induced constipation. (PubMed, Support Care Cancer) - "The concomitant use of MgO and naldemedine was associated with improved defecation, although no statistically significant interaction was detected. However, the added benefit of naldemedine may be limited at higher MgO doses. Naldemedine may be particularly effective in patients with constipation during opioid therapy that is insufficiently responsive to conventional laxatives, especially when an increase in MgO is difficult due to risks such as hypermagnesemia."

Journal • Retrospective data • Addiction (Opioid and Alcohol) • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology

Novel antiemetic effect of naldemedine in patients initiating opioids for cancer pain: A secondary analysis of a randomized clinical trial. (PubMed, Oncologist) - "Naldemedine may have intrinsic antiemetic potency to prevent both OIC and OINV."

Clinical • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain • Palliative care

Can Naldemedine Allow Higher Oxycodone Dosing in Patients with Cancer? A Single-Center Retrospective Study. (PubMed, J Palliat Med) - "Naldemedine enabled higher oxycodone dosing, suggesting OIC management reduces opioid switching."

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain