New Trial Marks a Further Step In Movetis’ Label Expansion Strategy for Resolor

Movetis NV, a European gastrointestinal (GI) specialty pharmaceutical company, has started a Phase III clinical trial with prucalopride in male patients with chronic constipation.

Movetis NV, a European gastrointestinal (GI) specialty pharmaceutical company, has started a Phase III clinical trial with prucalopride in male patients with chronic constipation. Positive results from this clinical trial programme should allow Movetis to support a regulatory application for expansion of the current label of Resolor (prucalopride).1

Approval of the regulatory application by the registration authorities would enable physicians to prescribe this medication for the treatment of male patients with chronic constipation. The expansion of the current label to include male patients could increase the target EU patient population for the product from 6 million to 7 million.

The screening of the first patients for the Phase III clinical trial with prucalopride in male patients with chronic constipation has now begun. This 12-week randomized, double-blind, placebo-controlled trial will run in nine European countries and involve 348 patients from nine European count