EMEA accepts Movetis' Resolor MAA

Belgian drug developer Movetis says that the European Medicines Agency (EMEA) has accepted its Marketing Authorization Application submission for Resolor (prucalopride) as a treatment for chronic constipation in adults in whom laxatives fail to provide adequate relief. The agent is a novel selective, high-affinity 5-HT4 receptor agonist that has the potential to improve the symptoms of people with abnormalities in gastrointestinal motility by restoring the smooth functioning of the lower GI tract. Chronic constipation affects more than 80 million people worldwide, of whom 37 million live in the European Union, noted the Turnhout-headquartered drugmaker. The MAA is supported by a development program consisting of three identical Phase III studies and by data derived from a comprehensive clinical trial program including an additional 79 trials, which fully explored the clinical profile of the drug for a variety of medical needs and patients, in a test population of 3,000, representing 2,500 patient years of exposure to the compound.