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Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
Date:9/13/2007

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 possible occurrence of diarrhea during treatment. If the diarrhea or nausea becomes severe, patients should consult their health professional.

In clinical trials for Chronic Idiopathic Constipation (24 mcg, oral gel capsules, twice daily), the most common adverse reaction was nausea (29%). Other adverse reactions (greater than or equal to 4% of patients) included diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distension (6%) and flatulence (6%).

For full prescribing information, visit http://www.amitiza.com.

AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., an emerging pharmaceutical company based in Bethesda, Md., focuses on the development and commercialization of drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. The therapeutic potential of prostones was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' chairman and chief ex
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SOURCE Sucampo Pharmaceuticals, Inc.
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