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New Drugs Online Report for naldemedine
Generic Name:
Trade Name:  
Synonym: S-297995 
Entry Type: New molecular entity  
Development and Regulatory status
UK: Phase III Clinical Trials 
EU: Phase III Clinical Trials 
US: Phase III Clinical Trials 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Trial or other data
Nov 13: NCT01993940 is a randomized, double-blind, placebo-controlled PIII study of naldemedine (0.2 mg once daily) in the treatment of opioid-induced constipation in 540 subjects with non-malignant chronic pain receiving opioid therapy. The primary efficacy endpoint is the proportion of responders who have a spontaneous bowel movement. The study starts Nov 13 and is due to complete Feb 16 [1]. 
26/11/2013 17:47:07
Available only to registered users
BNF Category:
Laxatives (01.06)
Pharmacology: Peripherally-selective μ-opioid receptor antagonist  
Epidemiology: Opioid-induced constipation is a side effect that affects nearly all patients taking opioid treatment and will persist unless treated. The prevalence of opioid-induced constipation is not known. However, in England in 2010 there were over 17 million prescriptions for opioid items. In 2010-11 there were 57,506 hospital admissions due to constipation in England, and in 2011, there were 57 deaths registered in England and Wales due to constipation.  
Indication: Constipation 
Additional Details: opioid-induced 
Method(s) of Administration
Company Information
Name: Shionogi 
US Name: Shionogi 
Further Information
Anticipated commissioning route (England)
High cost drug list? Awaiting Update
Implications Available only to registered users