Solvay Pharmaceuticals unveiled this week results from a six-month study of both male and female patients and from a subgroup analysis of males with Irritable Bowel Syndrome with Diarrhea predominance (IBS-D). Treatment with cilansetron resulted in significant benefits including overall IBS symptom improvement, relief of abdominal pain/discomfort and abnormal bowel habits (including diarrhea and urgency) in both men and women.
Among other results, the study showed that after six months, 59% of patients receiving cilansetron reported overall adequate relief of IBS symptoms, while specifically 61% reported relief of abdominal pain/discomfort, and 64% reported relief of abnormal bowel habits. The most common adverse effect was constipation, which occurred in 12% of cilansetron patients; other adverse effects included headache, abdominal pain, nausea and nasopharyngitis. No severe complications of constipation occurred. Three suspected cases of ischemic colitis events were reported; all resolved without complication.
These results were released during Digestive Disease Week (DDW) 2004, the annual international meeting for gastroenterologists, held May 15-20 in New Orleans, Louisiana, United States. More details on the study results are available on the internet, at www.solvaypharmaceuticals-us.com.
IBS is a chronic condition affecting more than one in ten men and women worldwide and may require long-term therapy.
“The results of this study suggest that cilansetron has the potential to significantly relieve the overall symptoms of IBS-D, improving the quality of life for men and women who struggle with this disease on a daily basis,” said Dr. Marc Bradette, Professor of Medicine, Laval University, Quebec City, Quebec.
If approved, cilansetron is expected to be the only new therapy available to treat IBS-D in both men and women throughout the world. Solvay Pharmaceuticals has completed three phase III efficacy studies. Solvay Pharmaceuticals submitted a new drug application for cilansetron in the United Kingdom on April 28, 2004, and plans to submit to the FDA in the United States in the second quarter of this year.
Solvay Pharmaceuticals is the pharmaceutical activities arm of Solvay. It is active in carefully selected indications within the fields of gastroenterology, gynaecology/andrology, cardiology and mental health. It employs more than 7500 people. For more information, go to www.solvaypharmaceuticals.com
Solvay is an international chemicals and pharmaceuticals group with headquarters in Brussels. It employs more than 30,000 people in 50 countries. In 2003 its consolidated sales amounted to EUR 7.6 billion generated by its four activity sectors: Chemicals, Plastics, Processing and Pharmaceuticals. Solvay is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com.