Movetis starts phase III clinical trial with prucalopride in male patients with chronic constipation

28-Sep-2010 - Belgium

Movetis NV announced that it 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).

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 twelve-week randomised, double-blind, placebo-controlled trial will run in nine European countries and involve 348 patients from nine European countries. Movetis expects to submit the data from this phase III trial late 2012-early 2013.

The regulatory application that was submitted to the European Medicine Agency (EMA) for the current, approved indication, was supported by the results of a clinical development programme with over 3,000 patients, of whom 511 were male patients. However, the current Resolor label confines its use to women with chronic constipation in whom laxatives have failed to provide adequate relief. This is because of the limited amount of efficacy and safety data with prucalopride in male patients with chronic constipation that was generated in previous clinical studies.

Dirk Reyn, CEO of Movetis commented: “We are pleased to be continuing to advance the development of Resolor as scheduled. The clinical trial programme that we initiated today is the latest step in a well-thought out label expansion strategy for Resolor. In May 2010, we started our first clinical trial with prucalopride in patients with opioid induced constipation, another area of significant unmet medical need. All of the additional indications that we are targeting could eventually double the current European patient population with disorders that could be treated with prucalopride.”

https://www.bionity.com/en/news/123442/movetis-starts-phase-iii-clinical-trial-with-prucalopride-in-male-patients-with-chronic-constipation.html