Men suffering from constipation in Europe can now get treatment with Shire’s Resolor after regulators issued another green light substantially expanding its reach.
The European Commission has approved Resolor (prucalopride) for the symptomatic treatment of chronic constipation in men when laxatives fail to provide adequate relief, following a green light for women in 2009.
Chronic constipation is estimated to affect up to 14% of the population - with an incidence rate of 17% in women and 9% in men - and can impact significantly on a patient’s quality of life.
Resolor is a selective, high-affinity 5-HT4 receptor agonist designed to stimulate bowel motility. Its approval was based on a Phase III trial in which 37.9% of patients taking the drug experienced normal bowel function compared to 17.7% in the placebo arm.
OK for Relistor
The EC also cleared Valeant/Progenics Relistor (methylnaltrexone bromide) jab for the treatment of opioid-induced constipation (OIC) when response to laxative therapy has not been sufficient in adult patients.
Relistor was first cleared for use in Europe in 2008 for the treatment of OIC in advanced illness patients.