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Cilansetron Given Priority Review Status by FDA

MARIETTA, Ga., September 01, 2004 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review of the company's New Drug Application (NDA) for cilansetron, an investigational 5-HT3 receptor antagonist, being studied for the treatment of irritable bowel syndrome with diarrhea predominance (IBS-D) in men and women. Products assigned for priority review by the FDA are those that appear to represent a potential therapeutic advance over existing therapies. The company is seeking approval to manufacture and market cilansetron for the treatment of IBS-D in the United States.

"We are pleased to announce that the cilansetron NDA has been accepted by the FDA for priority review," said Dr. Harold Shlevin, Solvay Pharmaceuticals, Inc. President and CEO. "We believe our clinical data demonstrate that cilansetron is safe and efficacious for the treatment of IBS-D in men and women, improving their quality of life. If granted FDA approval, we believe cilansetron will provide a significant treatment advance to address unmet needs of IBS-D sufferers."

The clinical data supporting the cilansetron NDA are based on efficacy and safety studies in approximately 4000 patients worldwide with IBS-D. The use of cilansetron in clinical trials resulted in significant relief of overall IBS symptoms, abdominal pain/discomfort, and abnormal bowel habits in men and women. Current 5-HT therapies indicated for IBS are approved for women only.

Solvay Pharmaceuticals' NDA submission includes a comprehensive appropriate use program based on collaboration with physicians, pharmacists, patients, and risk minimization experts. The cilansetron Appropriate Use Program (AUP) features an array of educational tools that the company intends to discuss with the FDA.

It is estimated that as many as 30-45 million men and women suffer with IBS in North America, with approximately one-third from IBS-D. Missing work, school or leisure activities due to IBS symptoms is common among sufferers. According to a study published in Gastroenterology in 2002, the total costs of IBS in the United States have been estimated at approximately $21 billion.

Source: Solvay Pharmaceuticals

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