New Data Presented at UEGW Confirm Effectiveness and Safety of Resolor for Patients with Chronic Constipation
Novel compound offers hope to patients not adequately responding to laxative treatment
PARIS, 30 October 2007. Data presented for the first time today at the international gastroenterology meeting UEGW (United European Gastroenterology Week) confirm the effectiveness and safety of RESOLOR® (prucalopride), a novel and selective, high-affinity 5-HT4 receptor agonist, for patients suffering from Chronic Constipation (CC) for whom laxatives do not provide adequate relief1.
Findings from this randomised, double-blind, placebo-controlled trial evaluating the effectiveness and safety of RESOLOR (2 mg and 4 mg) in patients with CC over 4 and 12 weeks demonstrated similar results for both doses, which were significantly different from placebo (p?0.01) at the primary endpoint, where the proportion of patients treated with RESOLOR having an average of ?3 spontaneous complete bowel movements (SCBM) more than doubled, over 4 and 12 weeks, versus the placebo group. RESOLOR also reduced perceived severity of symptoms, improved disease-related quality of life (QOL), and was safe and well tolerated.
Lead investigator Jan Tack, Professor and Head of Clinic, Division of Gastroenterology, University Hospital Gasthuisberg, University of Leuven, Belgium, commented “If not treated appropriately, CC can have a significant impact on patients’ well-being. The debilitating effects on work, mental health and relationships are often underestimated. Achieving three or more spontaneous complete bowel movements per week for a patient with CC can be considered a return to a normal bowel frequency. The data therefore confirm that treatment with RESOLOR, for this difficult to treat patient population, resulted in normalisation in approximately 25% of patients and a clinically meaningful improvement in an additional 20%. This is a clear step forward in treating a population in need of effective treatments.”
Dirk Reyn, CEO of Movetis, added “At Movetis we are committed to discover and develop products targeting gastrointestinal conditions previously neglected by innovation. These convincing Phase III data demonstrate that RESOLOR can really make a difference for the millions of patients who have tried laxatives without success. We are planning to file RESOLOR for European marketing approval in mid-2008.”
About the trial
This Phase III trial, the first of three identical, multicentre, parallel-group, randomised, double-blind, placebo-controlled trials, evaluated 713 patients (90.8% female, mean age approximately 43 years), with long-standing (at least 18 years of disease history on average) and more severe CC (<2 scbm)
• 10.4% and 9.6% for placebo
• 23.7% and 19.5% for 2 mg RESOLOR
• 26.6% and 23.6% for 4 mg RESOLOR.
The following secondary objectives were significantly improved
with 2 mg RESOLOR versus placebo (averaged over the 4- and 12-week
• percentage of patients with an increase of one or more SCBM/week (41.0% vs. 20.9% and 38.1 vs. 20.9%, respectively; p?0.001)
• percentage of bowel movements with normal consistency (p?0.05)
• percentage of BM with no straining (p?0.01)
• perceived severity of constipation (p?0.001)
• overall PAC-SYM scores (p?0.001).
• overall treatment satisfaction scores (p?0.001)
Similar findings (all statistically significant) were observed with 4 mg RESOLOR.
RESOLOR was reported safe and well tolerated, and no drug-related serious cardiac events were reported.
RESOLOR is a novel enterokinetic treatment for CC in a patient population not adequately relieved by laxative treatments. It is a selective, high-affinity 5-HT4 receptor agonist, which increases colon motility and restores the slow movement of the bowels in a dose-dependent manner. RESOLOR has now completed three Phase III studies and been tested in more than 3,000 patients. Movetis is planning to file for European marketing approval in mid-2008.
About Chronic Constipation (CC)
CC is a disorder of the gastro-intestinal (GI) tract. It is a prevalent and debilitating condition that is not always well understood and is in many cases inadequately treated. Different guidelines define CC as less than 3 bowel movements per week for at least 6 months. This is usually accompanied by pain and or excessive straining during the passage of a bowel movement. Patients often complain that stools are either too hard, too infrequent, too difficult to pass or incomplete and therefore unsatisfactory2. In Europe, an estimated 8.5 million patients frequently visit their doctors with complaints of constipation after dissatisfactory results with over-the-counter medication3. Constipation is more common in women than men (estimated prevalence ratio of 2.2:1)4. However, the true prevalence of CC is often underestimated since not all patients seek medical advice.
Posted: November 2007