TURNHOUT, Belgium, December 18 /PRNewswire/ -- The Gut and Alimentary Pharmacology and Therapeutics (APT) articles, together with the first paper on the pivotal Phase III data in the New England Journal of Medicine (NEJM) in May, 2008 complete the publication of the full pivotal Phase III data set on prucalopride. A data set that confirms the effectiveness and safety of treatment with prucalopride for patients with chronic constipation for whom laxatives do not provide adequate relief.
The objective of the phase III placebo-controlled trials (INT-6 and USA-13) was to determine the efficacy, safety, tolerability and impact on quality of life (QOL) of oral prucalopride (2mg and 4mg), given once daily, for 12 weeks in patients with chronic constipation. The international studies were conducted in 7 countries in Europe and in the US, entering respectively 720 and 641 patients.
On the INT-6 study the author Professor Jan Tack from the Division of Gastroenterology, Department of Internal Medicine, University Hospital Gasthuisberg Leuven, reported in Gut: "Prucalopride significantly and consistently increased the number of spontaneous complete bowel movements (SCBM) per week, it improved completeness of the bowel movement and alleviated constipation symptoms. Overall efficacy was maintained throughout the entire treatment period. This effective treatment of constipation and its relief of symptoms led to significant increases in patient satisfaction and their quality of life".
According to Professor Eamonn Quigley, Professor of Medicine and Human Physiology, University College Cork, Ireland and author of the paper in Alimentary Pharmacology and Therapeutics (APT) the findings of the USA-13 study add further weight to the growing body of evidence supporting the use of prucalopride. "The data show that patients with an average 22-year history of constipation experienced improved symptom relief and normalised bowel function."
Dirk Reyn, CEO of Movetis commented in conclusion: "We are pleased with the publication of all three positive phase III datasets in such highly respected, peer reviewed journals as NJEM, Gut and APT as it gives further credibility to the strength of our dataset and the convincing efficacy and safety data." More detailed information on the studies can be found on http://www.movetis.com / in the news, as well as in the UEGW slides - accessible through the homepage.
Prucalopride is a novel enterokinetic treatment, and the first compound in a new generation of selective, high-affinity 5-HT4 receptor agonists, specifically designed to restore impaired bowel motility. Prucalopride was filed for marketing approval in May 2008 in Europe and is currently under review by the EMEA and Swissmedic.
About chronic constipation
Chronic constipation is a general disorder of the gastrointestinal tract that affects an estimated 80 million people worldwide and at least 37 million in Europe.(1) It is a prevalent and debilitating condition with a clear impact on quality of life.
Through a clear focus on gastroenterology (GI), Movetis seeks to improve the lives of millions of patients - both adults and children - by discovering, developing and ultimately commercializing innovative treatments targeting GI conditions with a high unmet medical need. Movetis NV - founded in Belgium in December 2006 - aims to become a leading European specialty pharmaceutical organization focused on GI diseases.
(1) Opportunities in gastroenterology. Drug Discovery World - Winter 2007/8.
For further information contact Movetis:
Also have a look at the UEGW slides on http://www.movetis.com - homepage