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FDA Accepts Sucampo's sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
Date:9/17/2007

ipation, IBS with diarrhea and mixed IBS, depending upon stool consistency. Patients with IBS-C have hard or lumpy stools, but unlike patients with chronic constipation the frequency of bowel movements is not part of the diagnostic criteria.

It is the temporal relationship of pain, bowel habit and stool characteristics that is the most prominent feature of IBS-C. The hypersensitivity of the gastrointestinal system of individuals with IBS-C makes them more prone to experience the effects of even mild symptoms associated with defecation or a change in bowel habit. In contrast to chronic constipation, the treatment of IBS-C is directed toward the improvement of the dominant symptoms (abdominal discomfort/pain and stool consistency) rather than increasing the frequency of bowel movements.

About AMITIZA(R) (lubiprostone 24 mcg) Twice Daily for Chronic Idiopathic Constipation

AMITIZA (24 mcg, oral gel capsules, twice daily) is indicated for the treatment of Chronic Idiopathic Constipation in adults. AMITIZA should not be used in patients with a known gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

The safety of AMITIZA in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures. Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea.

AMITIZA should not be administered to patients that have severe diarrhea. Patients should be aware of the possib
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SOURCE Sucampo Pharmaceuticals, Inc.
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