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New Drugs Online Report for naldemedine
Information
Generic Name:
naldemedine 
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
Aug 15: Once-daily 0.2mg naldemedine met primary endpoint in PIII study (COMPOSE II, NCT01993940, n=553) for treatment Of opioid-induced constipation in pts with chronic non-cancer pain. Naldemedine improved the frequency of spontaneous bowel movement (SBM) vs. placebo over 12 weeks. Naldemedine was generally well-tolerated. The most common side effects were gastrointestinal disorders [4].  
04/08/2015 15:47:03
Mar 15: Shionogi report COMPOSE I (NCT01965158) met its primary and secondary endpoint. Naldemedine 0.2mg od improved the frequency of spontaneous bowel movement (SBM) compared with placebo over 12 weeks with a statistical significance [3]. 
02/06/2015 16:07:48
Oct 13: Compose III (NCT01965652) a phase III trial will study the long-term safety of naldemedine daily vs. placebo for the treatment of opioid-induced constipation in subjects with non-malignant chronic pain receiving opioid therapy. The primary outcome is number of major adverse cardiac events over a 1 year period. The study aims to enrol 1500 patients and is due to complete in May 16 [2]. 
30/03/2015 17:07:04
Aug 13: A phase III trial (NCT01965158; COMPOSE 1) to assess the safety and efficacy of naldemedine (0.2mg once daily) for the treatment of opioid-induced constipation in patients with non-malignant chronic pain is underway. Patients will receive naldemedine or placebo once daily for 12 weeks. The primary efficacy outcome is proportion of responders who have a spontaneous bowel movement. The study is due to complete in July 15 [2]. 
30/03/2015 17:00:53
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
   
References  
Available only to registered users
Category
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
Oral 
 
Company Information
Name: Shionogi 
US Name: Shionogi 
 
Further Information
Anticipated commissioning route (England) CCG 
High cost drug list? Awaiting Update
   
   
Implications Available only to registered users