Symproic (naldemedine) / Shionogi, Collegium Pharma 
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 7 Diseases   5 Trials   5 Trials   247 News 


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  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI
    [VIRTUAL] BEYOND ROME IV; CAN NALDEMEDINE CHANGE EXPECTATIONS OF TREATMENT RESPONSE IN OPIOID INDUCED CONSTIPATION? (Hall 1) -  Sep 12, 2020 - Abstract #UEGW2020UEGW_6168;    
    In RCTs, NLD elicited not only a higher likelihood of durable treatment response than PLB in OIC but it also conferred a higher quality of response measured either by stool frequency, symptom control, or health related QoL up to 52 weeks' treatment. The established definition of efficacy in OIC may not fully capture the benefit of effective treatments.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Hakko Kirin, Vafseo (vadadustat) / Akebia Therap, Otsuka, Mitsubishi Tanabe
    Efficacy and safety of vadadustat in patients with anemia associated with conservative chronic kidney disease (NDD-CKD) (Domestic Phase III study) () -  Aug 30, 2020 - Abstract #JSN2020JSN_334;    
    [Method] Phase III, randomized, open-label, active control study [Results] 304 NDD-CKD patients were assigned to the naldemedine group or the control group according to the dose adjustment algorithm...The mean Hb values ​​at 20 and 24 weeks, which are the main endpoints, were 11.66 g/dL (95% confidence interval 11.49, 11.84) in the nintedanib group and 11.93 g/dL (11.76, 12.10) in the control group, both of which were targets...Throughout the 52-week treatment period, there were no major safety concerns regarding the administration of this drug. [Conclusion] The efficacy and safety of this drug was demonstrated in Japanese patients with anemia associated with NDD-CKD.
  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI
    [VIRTUAL] COST EFFECTIVENESS OF NALDEMEDINE USED FOR OPIOID-INDUCED CONSTIPATION IN ACCORDANCE WITH UEG CONSENSUS IN THE UK (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_5519;    
    NLD was dominant over naloxegol, assuming discontinuation parity, in non-cancer chronic pain patients and dominant over subcutaneous methylnaltrexone in patients with cancer pain. Naldemedine is highly likely to be a cost-effective treatment option for patients with OIC who have previously received a laxative when used in accordance with European expert guidance regardless of the clinical setting.
  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI
    [VIRTUAL] BEYOND ROME IV; CAN NALDEMEDINE CHANGE EXPECTATIONS OF TREATMENT RESPONSE IN OPIOID INDUCED CONSTIPATION? (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_4793;    
    In RCTs, NLD elicited not only a higher likelihood of durable treatment response than PLB in OIC but it also conferred a higher quality of response measured either by stool frequency, symptom control, or health related QoL up to 52 weeks' treatment. The established definition of efficacy in OIC may not fully capture the benefit of effective treatments.
  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI
    [VIRTUAL] COST EFFECTIVENESS OF NALDEMEDINE USED FOR OPIOID-INDUCED CONSTIPATION IN ACCORDANCE WITH UEG CONSENSUS IN THE UK (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_3543;    
    NLD was dominant over naloxegol, assuming discontinuation parity, in non-cancer chronic pain patients and dominant over subcutaneous methylnaltrexone in patients with cancer pain. Naldemedine is highly likely to be a cost-effective treatment option for patients with OIC who have previously received a laxative when used in accordance with European expert guidance regardless of the clinical setting.
  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI
    [VIRTUAL] BEYOND ROME IV; CAN NALDEMEDINE CHANGE EXPECTATIONS OF TREATMENT RESPONSE IN OPIOID INDUCED CONSTIPATION? (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_2817;    
    In RCTs, NLD elicited not only a higher likelihood of durable treatment response than PLB in OIC but it also conferred a higher quality of response measured either by stool frequency, symptom control, or health related QoL up to 52 weeks' treatment. The established definition of efficacy in OIC may not fully capture the benefit of effective treatments.
  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI
    [VIRTUAL] COST EFFECTIVENESS OF NALDEMEDINE USED FOR OPIOID-INDUCED CONSTIPATION IN ACCORDANCE WITH UEG CONSENSUS IN THE UK (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_1559;    
    NLD was dominant over naloxegol, assuming discontinuation parity, in non-cancer chronic pain patients and dominant over subcutaneous methylnaltrexone in patients with cancer pain. Naldemedine is highly likely to be a cost-effective treatment option for patients with OIC who have previously received a laxative when used in accordance with European expert guidance regardless of the clinical setting.
  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI
    [VIRTUAL] BEYOND ROME IV; CAN NALDEMEDINE CHANGE EXPECTATIONS OF TREATMENT RESPONSE IN OPIOID INDUCED CONSTIPATION? (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_833;    
    In RCTs, NLD elicited not only a higher likelihood of durable treatment response than PLB in OIC but it also conferred a higher quality of response measured either by stool frequency, symptom control, or health related QoL up to 52 weeks' treatment. The established definition of efficacy in OIC may not fully capture the benefit of effective treatments.
  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI
    Review, Journal:  Naldemedine: A New Option for OIBD. (Pubmed Central) -  Jun 19, 2020   
    Head-to-head comparisons between naldemedine and the other PAMORAs are not available yet, but some considerations will be discussed based on the pharmacological and clinical data. As a whole, the available data suggest that naldemedine is a valid treatment option for OIBD, as it is a well-tolerated drug that alleviates constipation without affecting analgesia or causing symptoms of opioid withdrawal.
  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI
    Retrospective data, Journal:  A preliminary study of the effect of naldemedine tosylate on opioid-induced nausea and vomiting. (Pubmed Central) -  Mar 31, 2020   
    For patients with constipation, using NALD at an early stage of opioid initiation might have secondary benefits, such as relief from OINV, besides improvement of OIC. To confirm the effectiveness of NALD for OINV, the symptom grade and intensity during concomitant use of NALD should be observed in a future study.
  • ||||||||||  Symproic (naldemedine) / Shionogi, BDSI, Movantik (naloxegol) / AstraZeneca, RedHill, Relistor (methylnaltrexone bromide) / Ono Pharma, Progenics, Bausch Health
    PK/PD data, Review, Journal:  Peripheral Opioid Receptor Antagonists for Opioid-Induced Constipation: A Primer on Pharmacokinetic Variabilities with a Focus on Drug Interactions. (Pubmed Central) -  Mar 13, 2020   
    For example, unlike naloxegol or naldemedine, methylnaltrexone is not a substrate for CYP3A4 or p-glycoprotein; therefore, its plasma concentration is not altered when coadministered with concomitant medications that are CYP3A4 or p-glycoprotein inducers or inhibitors. With a better understanding of pharmacokinetic nuances of each PAMORA, clinicians will be better equipped to identify potential safety and efficacy considerations that may arise when PAMORAs are coadministered with other medications.
  • ||||||||||  Clinical, Journal:  The Evolving Role of Long-Term Pharmacotherapy for Opioid-Induced Constipation in Patients Being Treated for Noncancer Pain. (Pubmed Central) -  Feb 16, 2020   
    However, chronic pain management often extends beyond this 12-week boundary, resulting in health-care professionals questioning the safety and efficacy of continued treatment with OIC agents. This review evaluates available literature on long-term treatment of OIC in patients with chronic noncancer pain with lubiprostone, naloxegol, and methylnaltrexone as well as preliminary results of the recently completed naldemedine long-term trial, COMPOSE-3.
  • ||||||||||  Review, Journal:  Opioid receptors in the GI tract: targets for treatment of both diarrhea and constipation in functional bowel disorders? (Pubmed Central) -  Oct 24, 2019   
    This review provide a synthetic summary of the most recent literature on the use of drugs acting on mu-receptors to treat two prevalent functional bowel disorders, presenting with opposite bowel habit. Eluxadoline and naloxegol, methylnaltrexone and naldemedine are recently FDA and/or EMA approved drugs demonstrated to be effective and safe for treatment respectively of irritable bowel syndrome subtype diarrhea and opioid induced constipation.
  • ||||||||||  Symproic (naldemedine) / Shionogi
    Journal:  Naldemedine: A Review in Opioid-Induced Constipation. (Pubmed Central) -  Sep 20, 2019   
    Consistent with its mechanism of action, the most commonly reported adverse events were GI in nature. In conclusion, current data indicate that naldemedine is an effective and generally well-tolerated treatment option for opioid-induced constipation in patients with cancer pain or chronic non-cancer pain, with the convenience of once-daily oral dosing.
  • ||||||||||  Journal:  Evidence Based Review of Pharmacotherapy for Opioid-Induced Constipation in Noncancer Pain. (Pubmed Central) -  Sep 11, 2019   
    Overall, naldemedine was rapidly absorbed, and no safety or tolerability issues were noted at the doses evaluated. With risk of bias determined to be low to moderate, published data to date suggest that methylnaltrexone, naloxegol, and naldemedine may be appropriate to treat OIC in patients with CNCP.
  • ||||||||||  Symproic (naldemedine) / Shionogi
    EFFECT OF NALDEMEDINE ON FREQUENCY OF SPONTANEOUS BOWEL MOVEMENTS AND ASSOCIATED SYMPTOMS (Poster Exhibition - Hall 7) -  Aug 18, 2019 - Abstract #UEGW2019UEGW_3556;    
    P3
    Treatment with NAL over 12 weeks compared with placebo improved the frequency of bowel movements as well as the signs and symptoms of OIC frequently reported with bowel movements including perception of incomplete evacuation, need for straining, and hard stools. NAL was generally well tolerated.
  • ||||||||||  Symproic (naldemedine) / Shionogi
    Journal:  Minimal contribution of P-gp on the low brain distribution of naldemedine, a peripherally acting μ-opioid receptor antagonist. (Pubmed Central) -  Jul 26, 2019   
    While the brain-to-plasma concentration ratio (brain Kp) of naldemedine in the mdr1a/b knockout mice was 4-fold of that in the wild-type mice, the brain Kp in the mdr1a/b knockout mice was quite low (brain Kp < 0.1). These results suggest that the low brain distribution of naldemedine was due to the limited ability to cross the BBB rather than efflux by P-gp and therefore brain distribution of naldemedine would not be affected by concomitant administration of P-gp inhibitors or functional disorder of P-gp.
  • ||||||||||  Symproic (naldemedine) / Shionogi, Collegium Pharma
    Trial completion:  Long Term Safety of Naldemedine (clinicaltrials.gov) -  Apr 18, 2018   
    P3,  N=1246, Completed, 
    Initiation date: Oct 2018 --> Jan 2019 Active, not recruiting --> Completed