MHRA requests further information on Cilansetron, Solvay ‘s proposed treatment for irritable bowel syndrome with diarrhea predominance (D-IBS)
Solvay Pharmaceuticals announced today that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has completed its review of cilansetron, a novel drug for the treatment of irritable bowel syndrome with diarrhea predominance (D-IBS) in both men and women. The agency has concluded that it is unable to grant a marketing authorization without further clinical trials. Solvay Pharmaceuticals is examining its priorities and will discuss future steps with the MHRA and other experts for this product in Europe.
On average, IBS affects more than 11% of the EU population, with total annual direct costs 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 off work and interfering as well with home-based, social and leisure activities.
About Solvay Pharmaceuticals
Solvay Pharmaceuticals today is one of the top 40 pharmaceutical companies in the world and its ambition is to expedite its development even further over the next few years. Globally, Solvay Pharmaceuticals has more than forty-years experience treating IBS and is committed to the IBS community, providing therapies that can help them to manage this condition.
Solvay Pharmaceuticals holds a strong worldwide market position in carefully selected therapeutic areas (psychiatry, gastroenterology, female and male hormone therapy, cardiology and immunology) and has a well-diversified portfolio of products. Each year about 15% of pharmaceuticals sales are dedicated to research into new life-saving drugs in three major research centers in Europe and the US. Accelerated growth is based on development of own research products, acquisition of products and medium-sized companies, expanding sales forces and geographic markets and raising the output and effectiveness of R&D (with partners or alone).
SOLVAY is an international chemicals and pharmaceuticals group with headquarters in Brussels. It employs some 30000 people in 50 countries. In 2004 consolidated sales amounted to EUR 7.9 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com.