RELISTOR (methylnaltrexone), peripheral opioid receptor antagonist
GASTROENTEROLOGY - New indication
Opinions on drugs - Posted on May 23 2017
Reason for request
Renewal of inclusion
No clinical advantage demonstrated in the management of opioid-induced constipation in adult patients who do not have advanced illness and are not palliative care patients
- RELISTOR has marketing authorisation in the treatment of opioid-induced constipation in adults who do not have advanced illness and are not palliative care patients, when response to conventional laxatives has been insufficient.
- Its efficacy has been demonstrated versus placebo. A moderate effect size was observed for an increase in the proportion of rescue-free bowel movements within 4 hours (in the very short term). This endpoint is poorly suited to this chronic situation.
- The population included in the studies does not match the marketing authorisation indication: only a small number of patients aged 65 years and over were included. The results observed in this subpopulation are not significant whereas an elderly population will be the main users of this medicine.
- The most common adverse effects in the studies were abdominal pain, whereas the purpose of treatment is to improve patients’ quality of life.
Improvement in actual benefit
Évaluation des médicaments