Symproic (naldemedine) / Shionogi, Collegium Pharma 
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 7 Diseases   5 Trials   5 Trials   234 News 


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  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Journal:  Naldemedine and Magnesium Oxide as First-Line Medications for Opioid-Induced Constipation: A Comparative Database Study in Japanese Patients With Cancer Pain. (Pubmed Central) -  Apr 11, 2024   
    The incidence of addition, change, or dose increase was significantly higher in the naldemedine arm than in the magnesium oxide arm of the early prescription group (hazard ratio (95% confidence interval), 1.08 (1.00, 1.17); p=0.0402); the incidence was comparable between the arms of the non-early group. Conclusion These findings may provide valuable insights into real-world clinical treatment patterns and preliminary evidence for the selection of first-line medications to mitigate opioid-induced constipation in Japanese patients with cancer pain.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma, Movantik (naloxegol) / AstraZeneca, RedHill, Kyowa Kirin, Relistor (methylnaltrexone bromide) / Ono Pharma, Bausch Health
    Review, Journal:  Opioid-induced Constipation: Old and New Concepts in Diagnosis and Treatment. (Pubmed Central) -  Apr 5, 2024   
    The bowel functional index is the main tool for assessing the severity of OIC and for monitoring the response. The paper discusses the recent literature on the pathophysiology, clinical evaluation, and management of OIC and provides a pragmatic approach for its assessment and treatment.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Enrollment closed, Enrollment change:  Effects of a Peripherally Acting  (clinicaltrials.gov) -  Mar 21, 2024   
    P2/3,  N=74, Active, not recruiting, 
    Larger-scale randomized placebo-controlled studies of PAMORAs in cancer patients would strengthen existing evidence. Recruiting --> Active, not recruiting | N=120 --> 74
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Journal:  Naldemedine-induced opioid withdrawal with restlessness as the predominant symptom in a palliative care setting. (Pubmed Central) -  Jun 23, 2023   
    In the systematic review and meta-analysis, the use of PAMORAs (mainly methylnaltrexone) was safe and associated with a reduced intolerance to enteral feeding but no difference in the time to laxation. Patients receiving palliative care often exhibit psychiatric symptoms such as anxiety and depression, but OWS due to naldemedine should also be considered as a potential cause.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Trial completion date, Trial primary completion date:  Effects of a Peripherally Acting  (clinicaltrials.gov) -  Jun 7, 2023   
    P2/3,  N=120, Recruiting, 
    The patient ultimately required continuous deep sedation for refractory symptoms and died several days later. Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Mar 2024
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Journal:  Opioid withdrawal syndrome developing after long-term administration of naldemedine. (Pubmed Central) -  Mar 24, 2023   
    Naldemedine is effective and safe among cancer patients with poor PS. For patients receiving naldemedine, it is necessary to consider the possibility of OWS regardless of the period of administration in order to maintain patient quality of life.
  • ||||||||||  Journal:  An Update on The Use of Pharmacotherapy for Opioid-Induced Bowel Dysfunction. (Pubmed Central) -  Feb 27, 2023   
    The fundamental reason is the lack of head-to-head clinical trials providing inter- and intragroup comparisons between PAMORAs, laxatives, and secretagogue agents. These investigations must be accompanied by further valid biopharmaceutical and economic evaluations, paving the way for rational clinical judgment in each context.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Journal:  Survey of Prophylactic Administration of Naldemedine for Opioid-induced Constipation (Pubmed Central) -  Feb 2, 2023   
    This study suggests that patients initiated with strong opioid analgesics during hospitalization often presented with poor performance status, and it is important to pay attention to constipation even under NAL prophylaxis. However, the incidence of diarrhea was low, and the safety of NAL prophylaxis was considered to be good.
  • ||||||||||  Journal:  Opioids for pain. (Pubmed Central) -  Dec 22, 2022   
    Not yet recruiting --> Recruiting No abstract available
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Retrospective data, Journal:  Naldemedine versus placebo in opioid-induced constipation: a meta-analysis. (Pubmed Central) -  Dec 16, 2022   
    Naldemedine improves a variety of bowel function parameters while preserving analgesia, confirming its efficacy for patients with OIC. However, head-to-head trials are needed to establish naldemedine as treatment of first choice for laxative-refractory OIC.
  • ||||||||||  Review, Journal:  Management of Opioid-induced Constipation in Older Adults. (Pubmed Central) -  Dec 13, 2022   
    Because of the complex nature of absorption, distribution, metabolism, and excretion in the aging population, all agents used to treat OIC must be evaluated individually and reevaluated as patients continue to age. This review will serve as a guide to managing OIC in older adults.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma, Movantik (naloxegol) / AstraZeneca, RedHill, Kyowa Kirin
    Review, Journal:  The Impact of P-Glycoprotein on Opioid Analgesics: What's the Real Meaning in Pain Management and Palliative Care? (Pubmed Central) -  Nov 27, 2022   
    Peripherally acting mu-opioid receptors antagonists (PAMORAs), such as naloxegol and naldemedine, are substrates of P-gp, which prevent their penetration in the central nervous system. In our review, we explore the interactions between P-gp and opioidergic drugs, with their implications in clinical practice.
  • ||||||||||  lumacaftor (VX-809) / Vertex, Symproic (naldemedine) / Shionogi, Collegium Pharma
    Journal:  Targeting human thymidylate synthase: Ensemble-based virtual screening for drug repositioning and the role of water. (Pubmed Central) -  Oct 19, 2022   
    Further binding free energy calculations based on the Molecular Mechanics Poisson-Boltzmann Surface Area method revealed that Imatinib, Lumacaftor and Naldemedine scored -130.7 ± 28.1, -210.6 ± 29.9 and -238.0 ± 25.4 kJ/mol, respectively, showing good binding affinity for the candidates considered. Overall, the analysis of the molecular dynamics trajectory of the receptor-drug complexes revealed stable structures for Imatinib, Lumacaftor and Naldemedine, for the entire simulation time.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma, Relistor (methylnaltrexone bromide) / Ono Pharma, Bausch Health
    Review, Journal:  Mu-opioid antagonists for opioid-induced bowel dysfunction in people with cancer and people receiving palliative care. (Pubmed Central) -  Sep 20, 2022   
    Moderate-certainty evidence for methylnaltrexone on spontaneous laxations over two weeks suggests subcutaneous methylnaltrexone may improve bowel function in people receiving palliative care, but certainty of evidence for AEs was low. More trials are needed, more evaluation of AEs, outcomes patients rate as important, and in children.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Journal:  A peripheral opioid antagonist for treating urinary retention induced by opioids: A case report. (Pubmed Central) -  Sep 10, 2022   
    Methadone therapy was effective on pain intensity, but bladder dysfunction persisted...Thus, naldemedine 200 mcg was prescribed for relieving urinary retention...In this case report, the effect of the peripheral opioid antagonist was prompt and long-lasting. Future studies of this neglected adverse effect of opioids should be performed to confirm this observation.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Retrospective data, Journal:  A retrospective study of the efficacy and safety of naldemedine for opioid-induced constipation in thoracic cancer patients. (Pubmed Central) -  Aug 18, 2022   
    A total of 953 OIC cancer patients were treated with Naldemedine, and the response rate for Spontaneous Bowel Movements (SBM) is 72 % (95 % CI, p = 0.004). The efficacy and safety of naldemedine for thoracic cancer patients in clinical practice were comparable with those of prospective studies, which suggest that naldemedine may be effective and feasible for most thoracic cancer patients.
  • ||||||||||  Tabrecta (capmatinib) / Incyte, Novartis, Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Symproic (naldemedine) / Shionogi, Collegium Pharma
    Journal:  Multi-targeted drug repurposing approach for breast cancer via integrated functional network analysis. (Pubmed Central) -  Aug 12, 2022   
    The effect of Pimozide on EMT-induced MDAMB231 and MDAMB468 cells was evident from their IC50 values of 7.85 µM and 6.83 µM, respectively. The potent anti-cancer property of Pimozide has opened up avenues for drug repurposing towards 'multi-targeted therapy' in EMT dynamics.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Journal:  Efficacy Survey of Naldemedine in the Poor-performance Status Group (Pubmed Central) -  Jul 6, 2022   
    Furthermore, results of multivariate analysis showed that "best supportive care" and "body weight (55 kg and above)" reduced Nal efficacy. In conclusion, Nal showed similar effectiveness in patients with poor PS as that in those with good PS.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Retrospective data, Journal:  Nalmedine-laxative combination: retrospective inpatient study. (Pubmed Central) -  Jun 25, 2022   
    In conclusion, Nal showed similar effectiveness in patients with poor PS as that in those with good PS. The introduction of naldemedine alone or in combination with MgO should be considered.
  • ||||||||||  Review, Journal:  Constipation in Cancer Patients - an Update of Clinical Evidence. (Pubmed Central) -  Jun 11, 2022   
    Naldemedine, naloxegol, and methylnaltrexone are supported by quality evidence for OIC management. Naloxone or naltrexone, taken orally in combined formulations with opioids, may be valuable in preventing or reducing OIC symptoms.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Retrospective data, Journal:  Risk factors for opioid-induced constipation in cancer patients: a single-institution, retrospective analysis. (Pubmed Central) -  May 31, 2022   
    Naloxone or naltrexone, taken orally in combined formulations with opioids, may be valuable in preventing or reducing OIC symptoms. High BMI, chemotherapy including a taxane within 1 month of evaluation of laxative effect, no use of naldemedine, and addition or switching due to insufficient prior laxatives were identified as risk factors for OIC in advanced cancer patients with cancer pain.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Review, Journal:  Update on the role of naldemedine in opioid-induced constipation in patients with chronic noncancer pain. (Pubmed Central) -  May 6, 2022   
    It is generally well tolerated with a higher incidence of gastrointestinal adverse events of mild or moderate severity such as diarrhea, abdominal pain, or vomiting compared to placebo. While there are no randomized, controlled trials that compare head-to-head pharmacological therapies used for treatment of OIC, network meta-analysis shows that naldemedine has an overall good benefit-risk profile compared to the other approved medications.