Movetis obtains EU authorisation for the commercialisation of Resolor (prucalopride)
Movetis announced that it has obtained approval from the European Commission for the commercialisation of its lead product Resolor (prucalopride – a 1mg and 2mg once a day oral tablet) for the symptomatic treatment of chronic constipation (CC) in women in whom laxatives fail to provide adequate relief. Movetis will sell the product itself in certain European markets and expects the first launch in Q1 2010.
Prucalopride is a selective high affinity serotonin (5-HT4) receptor agonist with enterokinetic activity, indicated for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
The approval by the European Commission means that Resolor is now approved for marketing in the 27 countries of the EU as well as Iceland, Liechtenstein and Norway. As part of its post marketing commitments Movetis has agreed to conduct further clinical studies to investigate the safety and efficacy of prucalopride in the treatment of chronic constipation in males. Furthermore it intends to initiate a clinical program to test the product in children and in opioid-induced constipation.
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