A new treatment option for chronic constipation in women in whom laxatives have failed Malta, 15th June 2012 – Vivian Corporation, local partners of Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that Resolor® (prucalopride) is now available in Malta and Gozo, for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.1

Constipation is a common and generally mild and short-term complaint for most individuals. For a proportion of patients, however, constipation can be a chronic and sometimes severe and bothersome condition.2–5 It is estimated that 20% or more suffer from chronic constipation12. 

Chronic constipation is a multi-symptom and often bothersome disorder.3 A US survey published in 2007 assessed the frequency, severity and bothersomeness of commonly-reported symptoms of chronic constipation.3 Fifty-four percent of the 557 respondents suffering from chronic constipation considered constipation to be an “extremely”, “very” or “somewhat” severe medical condition and most respondents (76%) rated their constipation as “extremely”, “very” or “somewhat” bothersome. Abdominal bloating, straining and hard stools were ranked as the three most bothersome symptoms, and symptoms were considered more bothersome with increasing duration of this disorder (6 years or more).3 

Chronic constipation can impact significantly on quality of life (QoL). More than half of respondents (52%) in the 2007 US survey reported that constipation affected their QoL “somewhat”, “a lot” or “a great deal”, with a substantial 73% of respondents reporting social or personal impairment as a result of symptoms.3 Many patients with chronic constipation report an impact on their work life.3

Diet and lifestyle changes often represent the first approach to treatment of chronic constipation symptoms, although few data support their overall effectiveness.6 Patients who gain only limited symptom relief from these changes may benefit from one of a wide variety of laxatives that are available.6 Many of these laxatives are effective and well tolerated in most constipated patients. However, not all patients are satisfied with their treatment.3

The 5-HT4 receptor is involved in the stimulation of high-amplitude contractions and coordination of bowel motility7–9 and has thus become a target for symptomatic treatment of chronic constipation.

Resolor® (prucalopride), a selective, high-affinity 5-HT4 receptor agonist, is a gastrointestinal prokinetic that helps to restore bowel motility in chronic constipation.1,7,10,11  Its high affinity for the 5-HT4 receptor is likely to explain its prokinetic effects.1

 

The European approval of Resolor® in October 2009, for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief, was based on three multicentre, randomised, double-blind, 12-week placebo-controlled studies including 1,124 females with chronic constipation treated with Resolor®.1 The primary efficacy endpoint was the proportion of subjects that reached normalisation of bowel movements defined as an average of three or more spontaneous, complete bowel movements (SCBM) per week over the 12-week treatment period.1 Resolor® 2 mg was statistically superior (p≤0.01) to placebo at the primary endpoint in each of the three studies.1 Among the female patients in whom previous treatment had failed to provide adequate relief, the proportion of patients treated with the recommended dose of 2 mg Resolor® (n=458) that reached an average of ≥3 SCBM per week was 31.0% (week 4) and 24.7% (week 12), versus 8.6% (week 4) and 9.2% (week 12) on placebo.1  A clinically meaningful improvement of ≥ 1 SCBM per week, the most important secondary efficacy endpoint, was achieved in 51.0% (week 4) and 44.2% (week 12) treated with 2 mg Resolor® versus 21.7% (week 4) and 22.6% (week 12) of placebo patients. 

“The launch of Resolor® is a significant development in the management of chronic constipation in women,” said Dr Mario Vassallo, Head of the Gastroenterology Department at Mater Dei Hospital. “The symptomatology of chronic constipation is not restricted to the constipation alone, but includes other symptoms such as bloating, flatulence and abdominal discomfort. Resolor® has an effect on the overall symptoms of patients, not only on the frequency of bowel movements. The impact of chronic constipation goes beyond ‘simple’ constipation and affects patients’ lives in terms of other symptoms, side-effects and lack of effectiveness of drugs, loss of working days and productivity and complications such as anal fissure and irritation, haemorrhoids, rectal bleeding etc”.

“For many patients with chronic constipation, existing treatments do not provide long term and satisfactory relief from their condition,” said Shire Pharmaceuticals Medical Director, Dr Roger Tschopp. “Shire is proud that the launch of Resolor® in Malta provides healthcare professionals with a new treatment option to help improve the distressing and persistent symptoms of chronic constipation.” 

 

For further information please contact:

Marketing & Media

Hannah Cremonahannahcremona@viviancorp.com +356 2132 0338

 

Regulatory & Quality Affairs

Nathalie M. Randonnathaliemrandon@viviancorp.com +356 2132 0338

 

Medical Representative

Sarah Mifsudsarahmifsud@viviancorp.com+356 21320 338

 

References

1.Resolor Summary of Product Characteristics. Shire-Movetis NV. 2012.

2.Tack J, Müller-Lissner S, Stanghellini V, et al. Diagnosis and treatment of chronic constipation – a European perspective. Neurogastroenterol Motil 2011;23:697–710.

3.Johanson JF, Kralstein J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther 2007;25:599–608.

4.Belsey J, Greenfield S, Candy D, Geraint M. Systematic review: impact of constipation on quality of life in adults and children. Aliment Pharmacol Ther 2010;31:938–49.

5.Wald A, Scarpignato C, Kamm MA, et al. The burden of constipation on quality of life: results of a multinational survey. Aliment Pharmacol Ther 2007;26:227–36.

6.Drost J, Harris LA. Diagnosis and management of chronic constipation. JAAPA 2006;19:24–9.

7.Briejer MR, Bosmans JP, Van Daele P, et al. The in vitro pharmacological profile of prucalopride, a novel enterokinetic compound. Eur J Pharmacol 2001;423:71–83.

8.Briejer MR, Prins NH, Schuurkes JA. Effects of the enterokinetic prucalopride (R093877) on colonic motility in fasted dogs. Neurogastroenterol Motil 2001;13:465–72.

9.Gershon MD, Tack J. The serotonin signaling system: from basic understanding to drug development for functional GI disorders. Gastroenterology 2007;132:397–414.

10.Tack J, van Outryve M, Beyens G, Kerstens R, Vandeplassche L. Prucalopride (ResolorR) in the treatment of severe chronic constipation in patients dissatisfied with laxatives. Gut 2009;58:357–65.

11.Bouras EP, Camilleri M, Burton DD, McKinzie S. Selective stimulation of colonic transit by the benzofuran 5HT4 agonist, prucalopride, in healthy humans. Gut 1999;44:682–6.

12.Vassallo, M (personal communication) 06th July 2012