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news.Movetis has announced that the European Medicines Agency has accepted the marketing authorization application submission for Resolor as a treatment for chronic constipation in adults in whom laxatives fail to provide adequate relief.
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The application for marketing authorization is supported by an extensive clinical development program consisting of three identical Phase III studies and by data derived from a comprehensive clinical trial program including an additional 79 studies, which fully explored the clinical profile of Resolor for a variety of medical needs and patient populations.
The three pivotal studies were randomized, parallel-group and placebo-controlled, with a run-in period of two weeks and a treatment period of 12 weeks. The primary efficacy endpoint in these studies was the proportion of patients with a mean of three or more spontaneous complete bowel movements (SCBMs) per week over the 12 weeks of the study.
Resolor is a new selective, high affinity 5-HT4 receptor agonist, which has the potential to improve the symptoms of people with abnormalities in gastrointestinal (GI) motility by restoring the smooth functioning of the lower GI tract.