Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunc...( First Patient Enroll...),Health

First Patient Enrolled in Pivotal Studies

BETHESDA, Md., Sept. 13 /PRNewswire-FirstCall/ -- Sucampo Pharmaceuticals, Inc. (Nasdaq: SCMP) and Takeda Pharmaceuticals North America, Inc. today announced that the first patient has been enrolled in a Phase III study of lubiprostone (24 mcg, oral gel capsules, twice daily) for the treatment of Opioid-Induced Bowel Dysfunction (OBD). The OBD Pivotal Assessment of Lubiprostone (OPAL) program consists of two 12-week double-blind studies, followed by a nine-month open-label safety extension study. The double-blind studies are expected to enroll approximately 840 patients at up to 190 sites in the United States and Canada and will evaluate the effects of lubiprostone as a treatment for constipation stemming from the use of narcotic medications, such as morphine and codeine, prescribed for chronic pain management.

Lubiprostone, a chloride channel activator developed by Sucampo Pharmaceuticals, is currently approved for the treatment of Chronic Idiopathic Constipation in adults as AMITIZA(R) (24 mcg, oral gel capsules, twice daily) and is under FDA review for Irritable Bowel Syndrome with constipation. AMITIZA is marketed in the United States by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America.

"Each year, millions of patients who suffer from chronic pain are treated with opiates," said Egilius L. H. Spierings, M.D., Ph.D, Associate Clinical Professor of Neurology at Brigham and Women's Hospital, Harvard Medical School. "Many of these patients frequently develop severe constipation from these powerful analgesics; however, there are currently no approved prescription products available to treat this condition. This study is designed t
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