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Our lead product, Resolor (prucalopride), has recently (in october 2009) received the marketing approval for the symptomatic treatment of Chronic Constipation (CC) in women in whom laxatives fail to provide adequate relief in the EU27 and Iceland, Liechtenstein and Norway. A marketing authorisation application for Resolor (prucalopride) in Switzerland was submitted in May 2008 to Swissmedic and is still under review. A decision is expected in H1 2010.
Resolor (prucalopride) is the first of a new class of selective high affinity serotonin (5-HT4) receptor agonists with enterokinetic activity. In clinical studies, the efficacy of prucalopride was established in three multicentre, randomised, double-blind, 12-week placebo controlled studies in subjects with chronic constipation (n=1,279 on prucalopride, 1,124 females, 155 males).
Potential market
Chronic Constipation (CC) is a disorder of the gastrointestinal tract. It is a prevalent and debilitating condition that is not always well understood and, in many cases, is inadequately treated. Approximately 34 million patients in the 27 countries of the EU are affected by CC, and an estimated 14 million patients frequently visit their doctor with complaints of constipation after unsatisfactory results with over-the-counter medication or prescription laxatives. It is estimated that 35-50% of patients remain dissatisfied, the vast majority of whom are women.
The impact on the quality of life from CC has been compared to other long-term chronic conditions such as hypertension, diabetes, heart disease and depression. It is also associated with a significant burden on healthcare resources. Each year in the European Union and the United States, approximately 2 billion US dollars are spent on over-the-counter laxatives, the mainstay of therapy for constipation.
In 2008, the world laxative market was estimated in excess of $3 billion dollars.¹ Women suffering from CC are a sizable initial indication as it estimated that up to 85% of patients who visit the doctors office in Europe with CC being female.
Development program
Resolor’s EU approval was based on a marketing authorisation application that included a comprehensive clinical-development program of three large and identically designed pivotal Phase III studies in the target indication (i.e. for the symptomatic treatment of chronic constipation (CC) in women in whom laxatives fail to provide adequate relief).
Movetis is already working on expanding the potential use of Resolor (prucalopride) to other important indications and the company already has encouraging Phase II data for Resolor (prucalopride) suggesting the potential treatment of chronic constipation in males and children as well as opioid induced constipation and post-operative ileus. The use of prucalopride in these conditions will be further tested in Phase III studies.
Commercial rights
The approval of Resolor (prucalopride) by the European Commission means that Resolor (prucalopride) is now approved in the 27 countries of the EU as well as Iceland, Liechtenstein and Norway.
It is our intention to market Resolor (prucalopride) in certain European markets by itself including Germany, the UK, France and the Benelux. Movetis will also seek where necessary to broker partnerships to maximise the sales of Resolor in certain other European territories. It is expected that the first launch of Resolor will be in Germany in the first quarter of 2010.
Download the SmPC of Resolor (prucalopride).
¹ IMS Health