AMITIZA(TM) (lubiprostone) shown effective and well-tolerated in people older than age 65

AMITIZA(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.

"AMITIZA 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 AMITIZA 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. AMITIZA 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.

AMITIZA, 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. AMITIZA 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 AMITIZA 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 AMITIZA 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 AMITIZA (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 (less than or equal to 0.0286). Improvements in both stool consistency and bowel-straining rating were also observed in patients taking AMITIZA over those taking placebo. Additionally, fewer patients in the AMITIZA 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. "AMITIZA 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."

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About AMITIZA

AMITIZA is indicated for the treatment of chronic idiopathic constipation in the adult population. AMITIZA 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 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.

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 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%).

For full prescribing information, visit www.amitiza.com.

Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. (Sucampo) was founded in 1996 and is an emerging pharmaceutical company, based in Bethesda, Maryland. Under the direction of Sachiko Kuno, the company's president and CEO, it is transitioning itself from a research & development company to a fully integrated pharmaceutical company, which now employs a small yet specialized sales force. Sucampo R&D focuses on the development and commercialization of drugs based on prostones. The therapeutic potential of prostones was first identified by co-founder, CSO and COO, Dr. Ryuji Ueno. Sucampo is focused on developing prostones with novel mechanisms of action for the treatment of gastrointestinal, respiratory, vascular and central nervous system diseases and disorders for which there are unmet or underserved medical needs and significant commercial potential.

In October 2004, Sucampo entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market Sucampo's first approved product, AMITIZA(TM), in the United States and Canada. Sucampo's specialized sales force complements the efforts of Takeda by focusing on institutional and long-term care facilities.

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

Takeda Pharmaceuticals North America, Inc.

Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, cholesterol-lowering and gastroenterology treatments, and has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com.

About Digestive Disease Week

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 20-25, 2006, at the Los Angeles Convention Center. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.


Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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