Naldemedine (Rizmoic) for the treatment of opioid-induced constipation

Introduction

Naldemedine (trade name: Rizmoic) has been approved in Germany since February 2019 for the treatment of opioid-induced constipation in adults. It is a treatment option for people who have already had treatment with a laxative.

Severe, chronic pain caused by cancer or another serious, chronic disease is often treated with painkillers called opioids.

One typical side effect of opioid painkillers is constipation: Opioids attach to certain receptors in the bowel and reduce the movement of the bowel, causing stool to move more slowly through the bowel. Doctors refer to this as opioid-induced constipation. Over the course of several weeks, this constipation can become a major problem for patients.

Naldemedine prevents the opioid painkillers from attaching to the receptors in the bowel. This is supposed to relieve the constipation.

Application

Naldemedine is taken once daily in tablet form (200 μg naldemedine), ideally always at the same time of day.

The treatment is stopped when opioid painkillers are no longer used.

Other treatments

Various medications can be used to treat constipation, as well as medical products that are supposed to change the composition of the stool, for instance. If one of these treatments is not effective enough, various alternatives can be tried out. If it is not possible to use any of these treatments, the drugs methylnaltrexone, prucalopride or naloxegel can be used.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of naldemedine compared to the standard treatments for opioid-induced constipation in people who have already used other laxatives.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The IQWiG review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of naldemedine (Rizmoic).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Naldemedine (opioid-induced constipation) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-45. August 13, 2020. (IQWiG reports; Volume 958).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

Comment on this page

What would you like to share with us?

We welcome any feedback and ideas. We will review, but not publish, your ratings and comments. Your information will of course be treated confidentially. Fields marked with an asterisk (*) are required fields.

Please note that we do not provide individual advice on matters of health. You can read about where to find help and support in Germany in our information “How can I find self-help groups and information centers?

Created on September 10, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

How we keep you informed

Follow us on Twitter or subscribe to our newsletter or newsfeed. You can find all of our films online on YouTube.