SUCAMPO OBTAINS FDA APPROVAL FOR AMITIZA(TM) CAPSULES.

(Full text of a statement. Contact details follow below.)

BETHESDA, Md., Jan. 31 /PRNewswire-AsiaNet/ --

Sucampo Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved the new drug application for AMITIZA(TM) (lubiprostone) capsules, an oral treatment of chronic idiopathic constipation in adults. AMITIZA(TM) is the first selective chloride channel activator approved for therapeutic use and has been shown to offer effective relief of chronic idiopathic constipation in adults. This condition affects women more often than men and also affects older patients after the age of 65 more frequently.

The approval is primarily based on data from two pivotal, double-blind, placebo-controlled studies, which showed that approximately 60 percent of patients who used AMITIZA(TM) experienced a spontaneous bowel movement within the first 24 hours. Additionally, AMITIZA(TM) was shown to decrease abdominal bloating, abdominal discomfort and constipation severity when administered over the 6-12 month treatment period.

"AMITIZA(TM) provides an onset of action within 24 hours of administration and can provide relief of symptoms of constipation such as stool consistency and straining," said John F. Johanson, M.D., clinical associate professor, University of Illinois College of Medicine, and lead investigator on lubiprostone studies since the beginning of Phase 2 of development.

AMITIZA(TM) works by increasing fluid secretion and motility in the intestine, and thereby increasing the passage of the stool and alleviating symptoms associated with chronic idiopathic constipation.

AMITIZA(TM) is contraindicated in patients with a known hypersensitivity to the drug or its components, and in patients with a history of mechanical gastrointestinal obstruction. The safety of AMITIZA(TM) during pregnancy has not been evaluated. Women planning to use AMITIZA(TM) should confirm that they are not pregnant prior to start of medication. The most common side effects associated with AMITIZA(TM) treatment during clinical trials were nausea, diarrhea, and headache. Taking AMITIZA(TM) with a meal or food may reduce the symptoms of nausea.