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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

o determine whether lubiprostone can help many Americans who have constipation as a result of taking opioid-based drugs for chronic pain."

According to the American Pain Foundation, more than 50 million Americans suffer from chronic pain. Opioid-based pain relievers are widely prescribed for these patients, and many of them also develop opioid-induced bowel dysfunction.

Opioid drugs are known to increase absorption of electrolytes, including chloride, in the small intestine, contributing to the constipating effects of these analgesics. Lubiprostone, as a locally acting chloride channel activator, is being studied to evaluate if it may directly counteract this condition without interfering with the analgesic benefits of opioids. Should lubiprostone be approved as a treatment of OBD, Sucampo Pharmaceuticals believes it may fill an important unmet need in the market. Sucampo Pharmaceuticals expects to file a supplemental new drug application for this indication in mid-2009 if the results of these studies are positive.

About Opioid-Induced Bowel Dysfunction (OBD)

Opioid-Induced Bowel Dysfunction comprises a variety of gastrointestinal conditions inclusive of severe constipation brought about by the use of narcotic medications such as morphine and codeine, which are commonly referred to as opioids. Physicians prescribe opioids for patients with advanced medical illnesses as well as those undergoing surgery. Despite their pain- relieving effectiveness, opioids are known to produce gastrointestinal effects that lead to opioid-induced constipation, including inhibition of large intestine motility, decreased gastric emptying and hard stools.

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
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SOURCE Sucampo Pharmaceuticals, Inc.
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