CILANSETRON; Solvay Pharmaceuticals suspends registration activites in the U.S., while discussions in Europe continue
Solvay Pharmaceuticals announced today it has suspended regulatory activities for cilansetron with the United States regulatory agency, the Food and Drug Administration. Given the amount of clinical work requested and in the framework of the estimated potential market there, Solvay prefers to give priority to the development of other compounds in its research and development pipeline.
However, in the United Kingdom, the reference member state for Europe-wide registration, discussions on cilansetron with the Medicines and Healthcare products Regulatory Agency continue. Solvay expects to announce its decision for Europe during 2006.
Cilansetron, is a novel 5-HT3 receptor antagonist which decreases gastrointestinal motility, secretion, and sensation. Efficacy and safety studies have included more than 4,000 patients worldwide, both men and women, with diarrhea predominance (D-IBS). Both men and women recorded symptom improvements and improved quality of life.
On average, IBS affects more than 11% of the EU population, with total annual direct costs estimates of some £45 million in the UK alone. The common symptoms of D-IBS are diarrhea, abdominal pain/discomfort, and fecal urgency. 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 as well with home-based, social and leisure activities.
SOLVAY PHARMACEUTICALS is a research driven group of pharmaceutical companies in Solvay that seeks to fulfil carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, pancreatic enzymes, gastroenterology and men’s and women’s health. Solvay Pharmaceuticals employs about 13,000 people worldwide after the acquisition of Fournier Pharma in July 2005.
SOLVAY is an international chemicals and pharmaceuticals group with headquarters in Brussels. It is present in more than 50 countries and employs some 33,000 people in its Chemicals, Plastics and Pharmaceuticals activities. Including Fournier Pharma, its 2004 sales amounted to EUR 8.5 billion. Solvay is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com.