2008-05-29

New Published Data Support Safety and Efficacy of RESOLOR(R) for Treatment of Chronic Constipation


Turnhout, Belgium (ots/PRNewswire) -

- New Generation Compound Provides Significant Benefit inPatients who do not Adequately Respond to Laxatives

New phase III data for RESOLOR(R) (prucalopride) published todayin The New England Journal of Medicine (NEJM) shows statistically andclinically significant improvement of bowel function and reducedseverity of symptoms in patients with chronic constipation(1).Prucalopride is the most advanced in a new generation of selective,high-affinity 5-HT4 receptor agonists, specifically designed to helppatients for whom laxatives do not provide adequate relief.

In this randomized, placebo-controlled trial of 620 patients withsevere chronic constipation, the proportion of patients achieving theprimary study endpoint of average greater than or equal to 3spontaneous complete bowel movements per week (SCBM/week) wassignificantly higher in both Prucalopride groups (2mg and 4mg)compared with placebo over both 4 and 12 weeks of treatment.Additionally, Prucalopride significantly improved the secondaryefficacy endpoints, including satisfaction with bowel function andtreatment, abdominal and stool symptoms, perception of constipationseverity, and disease-related quality of life.

Jan Tack, Professor and Head of Clinic, Division ofGastroenterology, University Hospital Gasthuisberg, University ofLeuven, Belgium, commented, "These are valuable and relevant findingsbecause the demanding endpoint in this study combines both asubjective measure of the completeness of evacuation with anobjective measure of the number of bowel movements, reflecting reliefof chronic constipation and normalization of bowel function. The highselectivity of Prucalopride towards the 5-HT4 receptor offers thebenefit that patients are unlikely to suffer from the side effectsassociated with the older generation, nonselective compounds. Thismeets the needs of doctors and patients by offering an effectivetreatment with an improved side effect profile."

Dirk Reyn, CEO of Movetis, added, "We are pleased with thepublication of this data in NEJM because it gives credibility andsupport to the strength of our phase III dataset. It also reflectsthe need for a safe, efficacious treatment of chronic constipationwhich is currently unmet. For years, the impact of chronicconstipation has been underestimated and research relating to thiscondition has been much less than in other medical fields. In Europealone, approximately 10 million patients visit their doctors seekinghelp after unsatisfactory results with over-the-counter medications.We hope that RESOLOR(R) will help to improve the lives of thesepatients both in Europe and worldwide."

About the trial

The phase III trial, the second of three identical, multi-centre,parallel-group, randomized, double-blind, placebo-controlled trials,evaluated 620 adult patients with a history of chronic constipation(defined as less than or equal to 2 SCBM/ week for a minimum of 6months prior to the selection visit). In addition, patients had toexperience very hard or hard stools, a sensation of incompleteevacuation, or straining during defecation with at least 25% of theirbowel movements. The primary objective was to assess the proportionof patients reporting on average three or more SCBM/week during a 12week treatment period - a very demanding primary endpoint.

Patients received oral doses of 2mg or 4mg Prucalopride, oncedaily, for 12 weeks. Percentages of patients with greater than orequal to 3 SCBM/week averaged over 12 weeks respectively were:

- 12.0% for placebo

- 30.9% for 2mg Prucalopride

- 28.4% for 4mg Prucalopride.

The following secondary endpoints were significantly improvedwith 2mg and 4mg Prucalopride over 12 weeks:

- Percent of patients with an average increase of greater than orequal to 1 SCBM/week (p<0.001)

- Average number of spontaneous complete bowel movements per week(p<0.001)

- Percentage of bowel movements with normal consistency (p<0.001)

- Patients rating treatment effective or extremely effective(p<0.001)

- Stool and abdominal symptom scores (p<0.001)

- Percent of patients with an improvement of greater than orequal to 1 point on a disease specific and validated Quality of Lifescale (PAC-QOL) (p<0.001)

Prucalopride (2mg and 4mg) also significantly reduced time tofirst spontaneous complete bowel movements and reduced laxative useduring treatment compared to placebo (both p<0.001)

Prucalopride was well tolerated in this study population. Themost frequent Adverse Events were headache, nausea and diarrhea.There were no significant cardiovascular effects of treatment. Therewere no differences between treatment groups in lab values, vitalsigns or ECG parameters.

About RESOLOR(R)

RESOLOR (prucalopride ) is a novel enterokinetic treatment forchronic constipation in a patient population not adequately relievedby laxative treatments. It is a selective, high-affinity 5-HT4receptor agonist, which increases colon motility and restores theslow movement of the bowels in a dose-dependent manner. RESOLOR hascompleted three Phase III studies and has been tested in more than3,000 patients. Movetis filed for European marketing approval inApril 2008.

About chronic constipation

Chronic constipation is a disorder of the gastrointestinal tract.It is a prevalent and debilitating condition that is not always wellunderstood and in many cases inadequately treated. The ROME IIIguidelines define chronic constipation as two or more of thefollowing symptoms at least a quarter of the time for at least sixmonths: straining, lumpy or hard stools, a sensation of incompleteevacuation, a sensation of anorectal obstruction or blockage, and/orless than 3 defecations per week(2) . In Europe, an estimated 10million patients frequently visit their doctors with complaints ofconstipation after dissatisfactory results with over-the-countermedication(3). Constipation is more common in women than men(estimated prevalence ratio of 2.2:1)(4).

About Movetis

Through a clear focus on gastroenterology, Movetis seeks toimprove the lives of millions of patients - both adults and children- by discovering, developing and ultimately commercializinginnovative treatments targeting GI conditions with a high unmetmedical need. Movetis NV - founded in Belgium in December 2006 - aimsto become a leading European specialty pharmaceutical organizationfocused on GI diseases. Movetis has a broad GI portfolio with fourproducts in clinical development and four in preclinical, alladdressing important GI areas with fewer innovative products,including chronic constipation, ascites, paediatric reflux ininfants, diabetic gastroparesis and non erosive reflux disease. Inaddition, Movetis owns a large library of qualified lead compoundswith potential for development in disease areas such as secretorydiarrhea. The current portfolio has been licensed from JanssenPharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc., twoJohnson & Johnson (J&J) companies.

The current portfolio includes:

- RESOLOR (prucalopride), a compound for the treatment of chronicconstipation currently filed for review for Marketing Authorisationin Europe

- M0002, a selective V2 receptor antagonist compound for thetreatment of ascites that has concluded recruitment of a Phase IIatrial. Results are expected before the end of Q2 2008.

- M0003, a gastrokinetic compound for the treatment of paediatricreflux in infants and symptoms of gastroparesis, which has entered aPhase IIa clinical trial in Q1 2008.

- M0004, another gastrokinetic compound for motility complaintsrelated to non erosive or refractory gastro-oesophageal refluxdisease (GORD) ready to move into clinical development.

References

1. Camilleri M, Kerstens R, Rykx A, Vandeplassche L. APlacebo-Controlled Trial of Prucalopride for Severe ChronicConstipation. NEJM 2008 In Press

2. A Drossman (2006) Rome III: The new criteria. Chinese Journalof Digestive Diseases 7 (4) , 181-185.

3. IMS Health.

4. Higgins PD, Johanson JF. Epidemiology of constipation in NorthAmerica: a systematic review. Am J Gastroenterol 2004;99:750-9.

ots Originaltext: Movetis NVIm Internet recherchierbar: http://www.presseportal.de

Contact:Vicki Martin, Tel: +44(0)20-8439-9407, vmartin@axon-com.com; Sarah Griffin, Tel: +44(0)20-8439-9582, sgriffin@axon-com.com

Movetis NV

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