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

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

Pharmacological and rehabilitation strategies in opioid-induced constipation: an observational study. (PubMed, Front Rehabil Sci) - "After three-month, Naldemedine + Rehabilitation group showed significantly higher satisfaction levels compared to those on Naldemedine alone, as indicated by PAC-QoL total score and sub-score for satisfaction (p = 0.031, p = 0.0163). The implementation of a combined approach involving targeted physical exercise alongside Naldemedine treatment showed promising results in enhancing patients' satisfaction."

Journal • Observational data • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

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

Naldemedine for the Prevention of Recurrent Acute Pancreatitis: A Randomised, Double-Blind, Placebo-Controlled Trial. (PubMed, United European Gastroenterol J) - P2/3 | "Treatment with naldemedine was safe and well-tolerated and may reduce the risk of recurrent acute pancreatitis. A larger confirmatory trial is needed to verify these findings."

Clinical • Journal • Diabetes • Metabolic Disorders • Pain • Pancreatitis

NOCON: Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Professor Monique A. H. Steegers | Not yet recruiting ➔ Recruiting

Enrollment open • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology

The effectiveness and safety of naldemedine in treating opioid-induced constipation among non-cancer adult patients: updated meta-analysis. (PubMed, Expert Opin Drug Saf) - "Naldemedine 0.2 mg is effective for treating OIC in non-cancer patients and is generally well tolerated, with primarily mild-moderate AEs. Further studies should explore long-term safety and comparisons with other PAMORAs.This review was registered in the PROSPERO databases (CRD42023472575)."

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

PS04 Peripheral opioid pathway antagonists: a novel therapy for idiopathic chronic pruritus and nodular prurigo. (PubMed, Br J Dermatol) - "Naloxegol and naldemedine are peripherally acting μ-opioid receptor antagonists used in the treatment of opioid-induced constipation. Only one patient reported mild gastrointestinal side-effects immediately after commencing therapy; however, they continued with treatment and this subsided shortly after. These results suggest that peripheral μ-opioid receptor antagonists have the potential to be an effective treatment option for chronic pruritus; however, further studies are needed to confirm their efficacy."

Journal • CNS Disorders • Constipation • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Prurigo Nodularis • Pruritus

Establishing the minimal important change for Patient Assessment of Constipation Quality of Life questionnaire for the prevention of opioid-induced constipation in patients with cancer pain. (PubMed, Support Care Cancer) - "The MIC values for the PAC-QOL scales for OIC prevention ranged from 0.14 to 0.41 for the overall scale and from 0.20 to 1.80 for the satisfaction subscale. These findings enable the assessment of the preventive effect of interventions for OIC in patients initiating opioids for cancer pain."

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

NOCON: Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced Constipation: Clinical Outcomes and Patient Experience (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Professor Monique A. H. Steegers

New trial • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology

Naldemedine (Rizmoic®) for the treatment of opioid-induced constipation (PubMed, Rev Med Liege) - "Effectively managing pain also means paying attention to adverse effects such as OIC, which can impact patients' quality of life. In addition to traditional treatments, therapeutic alternatives like naldemedine, a selective peripherally acting μ-opioid receptor antagonist, are now available to help patients for whom standard solutions are insufficient."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Opioid-induced constipation in internal medicine: recognition and management pathways. (PubMed, Intern Emerg Med) - "In conclusion, we urge to expand awareness about OIC. The seven-step diagnostic-therapeutic pathway approach formulated by ECHO OIC is a pragmatic and scalable model to improve OIC management with emphasis on education, early intervention, monitoring, tailored pharmacologic strategies, and coordinated referral when necessary."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder

Naldemedine for the management of opioid-induced constipation in patients with cancer pain: A narrative review. (PubMed, Medicine (Baltimore)) - "A comprehensive search was conducted to identify primary articles on the clinical effectiveness and adverse effects of naldemedine in patients with cancer with OIC. Naldemedine is a well-tolerated and effective drug for treatment of OIC in patients with cancer, and its use is expected to increase."

Journal • Review • Addiction (Opioid and Alcohol) • Anesthesia • Constipation • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Oncology • Pain

Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study (clinicaltrials.gov) - P4 | N=120 | Recruiting | Sponsor: International University of Health and Welfare

New P4 trial • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology

Treatment of Opioid-Induced Constipation: Inducing Laxation and Understanding the Risk of Gastrointestinal Perforation. (PubMed, J Clin Gastroenterol) - "Management of OIC includes treatment with over-the-counter laxatives and peripherally acting μ-opioid receptor antagonists (PAMORAs; methylnaltrexone, naloxegol, naldemedine). Appropriate patient selection during laxation therapy for OIC, regardless of treatment plan, involves consideration of the overall risk versus benefit in patients at increased risk of perforation due to comorbid medical conditions, concurrent medications, or recent gastrointestinal procedures. After initiating treatment for OIC, clinicians should assess the effectiveness of laxation therapy and carefully monitor for signs of gastrointestinal perforation."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Factors for Discontinuation of Naldemedine Therapy in a Palliative Ward. (PubMed, In Vivo) - "A high CAR (≥0.888) was a risk factor for the discontinuation of naldemedine therapy in a palliative ward. Our results suggest that physicians and pharmacists should monitor CAR as a marker of malnutrition and systemic inflammation before initiating naldemedine therapy."

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

Efficacy of Naldemedine in opioid-induced constipation in cancer patients (PubMed, Zhonghua Yi Xue Za Zhi) - "Naldemedine improved QoL. Naldemedine shows promising efficacy and manageable safety in cancer pain patients with OIC."

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

Drug repositioning as a promising approach for the eradication of emerging and re-emerging viral agents. (PubMed, Mol Divers) - "Main repositioned drugs have included chloroquine, ivermectin, dexamethasone, Baricitinib, tocilizumab, Mab114 (Ebanga™), ZMapp (pharming), Artesunate, imiquimod, saquinavir, capmatinib, naldemedine, Trametinib, statins, celecoxib, naproxen, metformin, ruxolitinib, nitazoxanide, gemcitabine, Dorzolamide, Midodrine, Diltiazem, zinc acetate, suramin, 5-fluorouracil, quinine, minocycline, trifluoperazine, paracetamol, berbamine, Nifedipine, and chlorpromazine. This succinct review will delve into the topic of repositioned drugs that have been utilized to combat emerging and re-emerging viral pathogens."

Journal • Review • Chikungunya • Dengue Fever • Ebola Virus Disease • Hematological Disorders • Hepatology • Infectious Disease • Inflammation • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Timing of Naldemedine Initiation and Occurrence of Diarrhea in Patients Receiving Strong Opioid Analgesics: A Retrospective Study. (PubMed, Pharmacy (Basel)) - "Multivariate logistic regression analysis revealed that the delayed introduction of naldemedine was significantly associated with the development of diarrhea (odds ratio: 6.68, 95% confidence interval: 1.220-36.700, p = 0.028). Our analysis reveals that the simultaneous administration of naldemedine and oxycodone may prevent the development of diarrhea associated with naldemedine use for OIC."

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

Erratum: Naldemedine for Opioid-Induced Constipation in Patients With Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial. (PubMed, J Clin Oncol) - No abstract available

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology

Opioid withdrawal syndrome induced by naldemedine administration in a cancer patient without brain metastasis. (PubMed, Palliat Support Care) - "Even in patients without brain metastasis, naldemedine can induce opioid withdrawal symptoms, so caution is required with patients receiving this drug. In addition, when psychiatric symptoms are pronounced, as in this case, withdrawal symptoms may be underdiagnosed."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Hepatology • Liver Cancer • Mood Disorders • Oncology • Pain • Psychiatry • Solid Tumor