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Amitizia (Lubiprostone) Shown Effective and Well-Tolerated in People Older than Age 65, a Population Considerably Affected by Chronic Idiopathic Constipation

LOS ANGELES, C.A. -- May 21, 2006 -- Amitizia(TM) (lubiprostone), the first selective chloride channel activator for the treatment of chronic idiopathic constipation, was effective and well-tolerated in treating the symptoms of chronic idiopathic constipation in the elderly adult population according to findings presented during a poster session today at Digestive Disease Week 2006.

"Amitizia is unique among prescription treatments for chronic idiopathic constipation, given its novel mechanism of action, which has been shown to provide targeted and predictable relief to people living with this condition," said John Johanson, M.D., clinical associate professor, University of Illinois College of Medicine. "These results further support that Amitizia may fill an important unmet need for many patients, especially those over age 65, for whom there are limited prescription treatment options currently available to treat chronic idiopathic constipation."

Predictable relief is defined as the ability of study participants to have three spontaneous bowel movements or more per week.

Constipation is one of the most common digestive complaints, affecting more than 30 million Americans, and is especially prevalent in adults over the age of 65. It is the cause of 2.5 million visits to physicians and 92,000 hospitalizations annually. Amitizia is the only prescription medication for chronic idiopathic constipation that can be used in people age 65+ for longer than two weeks. Approximately one of four patients over 65 suffers from chronic constipation, a condition that increases with age-related bowel changes.

Amitizia, approved by the U.S. Food and Drug Administration (FDA) in January 2006, is an oral treatment that works by increasing fluid secretion in the small intestine by activating ClC-2 chloride channels, and thereby increasing the passage of the stool and improving symptoms associated with chronic idiopathic constipation. Amitizia was developed by Sucampo Pharmaceuticals, Inc., and is jointly marketed in the United States by Sucampo and Takeda Pharmaceuticals North America, Inc.

Study Design
To evaluate symptom relief and the safety profile of Amitizia in the elderly adult population, data from three short-term (3-4 weeks), well-controlled clinical studies were pooled together to obtain an adequate group of adults over age 65. In total, 57 patients were included in the analysis: 26 participants received Amitizia 24 mcg taken twice daily, and 31 participants received placebo.

The findings reveal that mean changes from baseline in spontaneous bowel movements (SBMs) were significantly greater in the group treated with Amitizia (4.6-5.4 additional SBMs per week) versus the placebo group (1.29-2.27 additional SBMs per week) during weeks 1, 3 and 4 (P less than or equal to 0.0286). Improvements in both stool consistency and bowel-straining rating were also observed in patients taking Amitizia over those taking placebo. Additionally, fewer patients in the Amitizia group experienced adverse events (46.2%) compared to placebo-treated patients (61.3%).

"Constipation affects as many as 26 percent of men and 34 percent of women over 65 years of age," said Art Rice, general manager, gastroenterology, at Takeda Pharmaceuticals North America, Inc. "Amitizia is the only prescription medication for chronic idiopathic constipation approved for use in patients regardless of age or gender, and this data further underscores its benefits in older adults."

About Amitizia
Amitizia is indicated for the treatment of chronic idiopathic constipation in the adult population. Amitizia should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating Amitizia treatment.

The safety of Amitizia in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. Amitizia 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 Amitizia and should be capable of complying with effective contraceptive measures.

Amitizia 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 becomes severe, patients should consult their health professional.

In clinical trials, the most common adverse event was nausea (31%). Other adverse events (greater than or equal to 5% of patients) included diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain (7%), flatulence (6%), sinusitis (5%) and vomiting (5%).


Amitizia is a trademark of Sucampo Pharmaceuticals, Inc.


SOURCE: Sucampo Pharmaceuticals, Inc.; Takeda Pharmaceuticals North America

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