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Cilansetron Appears to Improve Health Related Quality of Life in Patients with Irritable Bowel Syndrome with Diarrhoea Predominance: Presented at ACG

WEESP, THE NETHERLANDS -- November 2, 2004 -- In a sub sample analysis of IBS-D subjects that completed a Phase III, six-month, multinational trial, treatment with cilansetron resulted in significant improvement of health related quality of life (HRQOL) in both men and women. The largest improvements were observed for the interference with activity, food avoidance, and dysphoria. Also presented, was additional efficacy data from a Phase III U.S. study, further demonstrating the significant treatment benefits among subjects who received cilansetron, including improvement in overall IBS symptoms, abdominal pain/discomfort and abnormal bowel habits. These data were presented this week during the annual meeting for the American College of Gastroenterology (ACG).

Cilansetron is an investigational 5-HT3 receptor antagonist, being studied for the treatment of irritable bowel syndrome with diarrheoa predominance (IBS-D) in men and women. 5-HT3 antagonists inhibit 5-HT3 receptors, resulting in decreased GI motility, secretion, and pain sensation, thus improving symptoms of IBS. Current 5-HT3 therapy indicated for IBS is approved for women only.

"These data are significant because it's rare to capture quality of life data specific to IBS-D in both men and women on a multi-national level," said Professor Stefan Mueller-Lissner, Professor of Medicine, Park-Klinik, Weissensee, Berlin, Germany. "Cilansetron could improve the quality of life for many worldwide as IBS is known to affect millions of people globally."

Penny Nunn of the IBS Network, a UK-based patient organisation, says, "IBS is a debilitating condition which can have a devasting impact on people's quality of life. Effective symptom control is fundamental in improving the lives of men and women who struggle with IBS on a daily basis."

In the US, IBS is a leading cause of worker absenteeism and according to a recent UK study, gastrointestinal disorders may account for one fifth of work absences and therefore may cost the UK £2 billion per year.

Study Details
Efficacy of cilansetron compared to placebo on HRQOL
In a Phase III, six-month, multinational study, subjects (ages 18-84), meeting the Rome criteria for IBS-D, were randomised to receive cilansetron 2 mg three times daily (TID) or placebo. A subgroup of 157 male and 181 female subjects completed an IBS-QOL survey, a validated 34-item condition-specific, quality-of-life measure consisting of eight subscales (interference with daily activity, body image, health worry, food avoidance, social reaction, sexual, relationship, and dysphoria), at day 1 of randomisation and after 6 months of treatment.
Ø Subjects showed total improvements of 17.7 for cilansetron vs. 9.6 for placebo in HRQOL scores (p<0.005)
Ø Lower scores at baseline at day 1 and after 6 months of treatment indicated lower HRQOL. Higher scores after six months of treatment indicated a higher HRQOL.
Ø Results for cilansetron were statistically significant from placebo (p<0.005) for all subscales except the sexual subscale (p=0.169)
Ø The sexual subscale showed the highest score at baseline and treatment reflects a trend in favour of cilansetron


Cilansetron in IBS-D: Efficacy and Safety in a Three-Month US Study
In a Phase III study, 205 males and 487 females meeting the Rome criteria for IBS-D, were randomised to receive cilansetron 2 mg TID or placebo for three months. An interactive voice response system was used to collect weekly data concerning relief of IBS symptoms, abdominal pain/discomfort, and abnormal bowel habits.
Ø The primary efficacy parameter was the proportion of subjects who reported adequate relief of IBS symptoms on at least 50% of their weekly responses while receiving treatment
Ø After three months, 49% of subjects (male and female) receiving cilansetron reported overall adequate relief of IBS symptoms versus 28% of subjects receiving placebo (p< 0.001), while specifically 52% receiving cilansetron versus 37% who received placebo (p<0.001) reported relief of abdominal pain/discomfort, and 51% in the cilansetron group versus 26% in the placebo group (p<0.001) reported relief of abnormal bowel habits
Ø The most common adverse effect was constipation, which occurred in 19% of subjects receiving cilansetron versus 4% in the placebo group; other adverse effects included headache and abdominal pain
Ø No severe complications of constipation occurred. There was one suspected case of ischaemic colitis which was transient and resolved without complication within 9 days.

Drug and Study Status
If approved, cilansetron is expected to be the only 5-HT3 therapy available to treat IBS-D in both men and women throughout the world. Solvay Pharmaceuticals has completed three phase III efficacy studies. A new drug application (NDA) was submitted to the FDA in the United States on June 30, 2004, and a registration dossier to the MHRA in the UK on April 28, 2004. The product has been assigned priority review by the FDA in the United States.

Appropriate Use Programme
Solvay Pharmaceuticals' NDA submission in both the US and the UK includes a comprehensive appropriate use program based on collaboration with physicians, pharmacists, patients, and risk minimisation experts. The cilansetron Appropriate Use Programme (AUP) features an array of educational tools and specific promotional strategies that the company intends to discuss with the FDA.

About IBS
IBS is a chronic condition affecting more than one in ten men and women worldwide and may require long-term therapy. The common symptoms of IBS-D are Diarrhoea, abdominal pain/discomfort, and faecal urgency. IBS-D is a chronic condition that may require long-term therapy. Symptoms of IBS-D vary widely in occurrence and intensity among patients. IBS has a significant negative impact on the quality of life for the many men and women who suffer from this condition, causing lost days of work and interfering with home-based, social and leisure activities.




SOURCE: Solvay Pharmaceuticals B.V.

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