Randomised clinical trial: the long‐term safety and tolerability of naloxegol in patients with pain and opioid‐induced constipation

  title={Randomised clinical trial: the long‐term safety and tolerability of naloxegol in patients with pain and opioid‐induced constipation},
  author={Lynn R. Webster and W. D. Chey and Jan Tack and Jaakko Lappalainen and Ulysses Diva and Mark Sostek},
  journal={Alimentary Pharmacology \& Therapeutics},
Opioid‐induced constipation (OIC) is a common adverse effect of opioid therapy. 

▼Naloxegol for opioid-induced constipation

  • Medicine, Biology
    Drug and Therapeutics Bulletin
  • 2015
The evidence for naloxegol is reviewed and its place in the management of opioid-induced constipation in adults who have had an inadequate response to laxative treatment is considered.

There is relief for constipated patients taking opioids.

A critical appraisal and clinical application of naloxegol in patients with opioid-induced constipation and laxative-inadequate response and its effectiveness and safety are evaluated.

Opioid-Related Side Effects and Management.

The following areas will be discussed in relation to opioid-related side effects and approaches to their management in the cancer patient.

Peripheral acting mu opioid receptor antagonists in the treatment of opioid-induced constipation: review

  • Medicine
  • 2020
The available information about PAMORAs is reviewed and informed strategy on the use of these drugs is proposed, which should be their role in the manangement of the CIO.

Naloxegol: A Review of Its Use in Patients with Opioid-Induced Constipation

Naloxegol demonstrated clinical efficacy and was well tolerated in placebo-controlled trials in patients with non-cancer pain and opioid-induced constipation, including those with an inadequate response to laxatives, and wasWell tolerated in a long-term safety study.

Long-term use of naldemedine in the treatment of opioid-induced constipation in patients with chronic noncancer pain: a randomized, double-blind, placebo-controlled phase 3 study

Naldemedine significantly increased bowel movement frequency, improved symptomatic burden of opioid-induced constipation, and increased patients' quality of life vs placebo in a 52-week, randomized, double-blind, phase 3 study.

Peripherally acting μ-opioid receptor antagonists as treatment options for constipation in noncancer pain patients on chronic opioid therapy

Peripherally acting μ-opioid receptor antagonists have been clinically tested to improve bowel symptoms without compromise to pain relief, although there are associated side effects, including abdominal pain.

Clinical utility of naloxegol in the treatment of opioid-induced constipation

Naloxegol is the first orally dosed PAMORA indicated for the treatment of OIC in noncancer patients and suggests its efficacy in patients failing traditional constipation treatments; however, insufficient evidence exists to establish its role in primary prevention of OI at this time.

Naldemedine in Japanese patients with opioid-induced constipation and chronic noncancer pain: open-label Phase III studies

The data suggested that naldemedine can improve bowel function and QOL in Japanese patients with OIC receiving regular-use opioids or prolonged-release oxycodone for chronic noncancer pain.



Trends in long‐term opioid therapy for chronic non‐cancer pain

To report trends and characteristics of long‐term opioid use for non‐cancer pain for non-cancer pain, a large number of patients with a history of abuse or dependence are surveyed for the first time.

Opioid-Induced Constipation: Challenges and Therapeutic Opportunities

  • M. Camilleri
  • Medicine, Biology
    The American Journal of Gastroenterology
  • 2011
Novel patient response outcomes have been developed to facilitate demonstration of efficacy and safety of drugs in development for OIC: prolonged release formulations that contain naloxone and a new class of peripherally restricted μ-opiate receptor antagonists.

Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness: A 3-Month Open-Label Treatment Extension Study

SC methylnaltrexone administered PRN for up to 3 months continued to rapidly induce laxation in advanced illness patients with OIC and patient and investigator global clinical impression of change scores improved.

Non-analgesic effects of opioids: management of opioid-induced constipation by peripheral opioid receptor antagonists: prevention or withdrawal?

  • P. Holzer
  • Medicine, Biology
    Current pharmaceutical design
  • 2012
Clinical studies show that more than 50 % of the patients with constipation under opioid therapy may benefit from the use of PORAs, while PORA-resistant patients are likely to suffer from non-opioid-induced constipation, the prevalence of which increases with age.

Treatment of opioid-induced constipation with oral naloxone: a pilot study.

Oral naloxone ameliorates opioid-induced constipation in opioid-dependent persons and Titration of dose to a maximum of 12 mg at least 6 hours apart may be needed to avoid adverse reactions.

Naloxegol for opioid-induced constipation in patients with noncancer pain.

Treating naloxegol, an oral, peripherally acting, μ-opioid receptor antagonist, for the treatment of opioid-induced constipation resulted in a significantly higher rate of treatment response, without reducing opioid-mediated analgesia.


Excerpt Drug addiction is a condition in which an individual has become sufficiently subject to an effect of a drug that he can no longer exert adequate self-control with regard to its continued us...

Opioid-induced bowel dysfunction: prevalence, pathophysiology and burden

Patients with OBD suffer from a wide range of symptoms including constipation, decreased gastric emptying, abdominal cramping, spasm, bloating, delayed GI transit and the formation of hard dry stools.

Novel opioid antagonists for opioid-induced bowel dysfunction

This study aims to provide a better understanding of the mechanism of action and reviews the efficacy, safety and the latest research on novel opioid antagonists for OBD.