New study demonstrates that AMITIZA™ (lubiprostone) may help improve symptoms

A new study found that AMITIZA(TM) (lubiprostone) may help relieve the symptoms associated with constipation-predominant irritable bowel syndrome (IBS-C). IBS is a condition that affects nearly 30 million people in North America and accounts for 25-50 percent of referrals to gastroenterologists. The study was presented today at Digestive Disease Week, the largest annual meeting of digestive disease specialists.

"The results of this study suggest that AMITIZA may help improve several of the most frequently reported symptoms of IBS-C, including abdominal pain, bloating and discomfort," said John Johanson, M.D., primary investigator and clinical associate professor, University of Illinois College of Medicine. "There are several additional studies underway that further explore the uses of AMITIZA in this patient population and we look forward to learning the findings."

AMITIZA is a novel selective chloride channel activator that has been shown to be effective and well-tolerated in a number of well-controlled clinical trials in patients with chronic idiopathic constipation. AMITIZA was approved for use for chronic idiopathic constipation in adults on January 31, 2006. This is the first time AMITIZA has been tested exclusively in the IBS-C population.

About the Study

In a double-blind, placebo-controlled, dose-ranging study, approximately 200 patients with diagnosed IBS-C (per the Rome II criteria) were randomized to receive placebo or AMITIZA (8, 16 or 24 micrograms) twice-daily for 12 weeks. In an electronic diary, patients recorded data related to dosing, side effects and IBS-C symptoms including bloating, abdominal pain/discomfort, frequency of and straining during bowel movements, stool consistency and rescue medication use.

Significant improvements versus placebo were observed for at least two of the three months for abdominal pain/discomfort, abdominal bloating, frequency of spontaneous bowel movements (SBM), stool consistency, bowel straining and assessments of constipation severity. Comparisons between the groups revealed that during the first and second months, the improvements in abdominal discomfort/pain and SBM frequency rates were more than doubled in all AMITIZA groups.

Overall, the improvements were typically highest in the highest AMITIZA dose group (48 micrograms/day). Dose-dependent trends were also seen for adverse events, with incidence and drop-out rates rising with the dose of AMITIZA.

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About Irritable Bowel Syndrome (IBS)

Irritable bowel syndrome (IBS) is a chronic disorder characterized by multiple symptoms of abdominal pain and discomfort, bloating, and changes of bowel habits such as constipation and/or diarrhea. The condition can significantly interfere with daily activities and reduce patients' quality of life, resulting in absences from school, missed work and reduced productivity.

Three main types of IBS exist: constipation-predominant (IBS-C), diarrhea-predominant (IBS-D) and alternating constipation and diarrhea (IBS-A). In IBS-C, symptoms are present for at least 12 weeks (these do not need to be consecutive) over a 12-month period. Although people with IBS-C report suffering from many of the same symptoms associated with constipation, the presence of pain and discomfort is what differentiates IBS-C from chronic constipation. The condition is approximately 2 to 2.5 times more prevalent in women than men, and women are more likely to report a history of constipation, whereas men are more likely to report diarrhea.

About AMITIZA AMITIZA, approved by the U.S. Food and Drug Administration (FDA) in January 2006 for the treatment of chronic idiopathic constipation in adults, 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 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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