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).