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Phase II Study Initiated for Treatment of Constipation-Predominant IBS

BETHESDA, Md., April 28 /PRNewswire/ -- Sucampo Pharmaceuticals, Inc. (www.sucampo.com), a leader in functional fatty acid research and development, announced today it has initiated a multi-center, safety and efficacy study for the treatment of constipation-predominant irritable bowel syndrome (IBS) with its proprietary agent SPI-0211, a novel chloride channel activator.

The Sucampo study will randomize 200 patients with documented constipation-predominant IBS into four treatment groups. The study will be conducted at 20 sites throughout the United States.

"IBS is a common and bothersome gastrointestinal condition, with limited standardized treatment," said Sucampo Chair and CEO Ryuji Ueno, M.D., Ph.D., PhD. "Sucampo is committed to researching, developing and commercializing safe, innovative pharmaceuticals that enhance the quality of human life. Because early research on this agent has shown promise for treating this challenging condition, we are particularly pleased to initiate this study as part or our comprehensive development program for SPI-0211."

According to the American Gastroenterological Association, the cause of IBS is not known and it has no cure. The condition causes a great deal of discomfort and distress for its sufferers, including painful cramps, gassiness, bloating, and changes in bowel habits. These symptoms, while not life threatening, can significantly interfere with the sufferers' daily activities (going to work, attending social events) and reduce their quality of life.

It is estimated that IBS accounts for up to 3.5 million physician visits per year in the Untied States.

Results from a phase III efficacy trial for the treatment of occasional constipation using SPI-0211 will be presented next month at the Digestive Disease Week 2003 Conference in Orlando.

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