Washington, D.C. - May 21, 2007 -- A new study demonstrated that the active ingredient in AMITIZA® (lubiprostone), given 8 mcg twice a day, may improve symptom relief rates in adults with irritable bowel syndrome with constipation (IBS-C). These results were presented as a late-breaker at Digestive Disease Week 2007, the largest annual international meeting of digestive disease specialists.
"In this study, patients receiving lubiprostone were nearly twice as likely to achieve an overall response from symptoms of IBS-C compared to those receiving placebo," said Douglas A. Drossman, M.D., primary investigator, UNC Center for Functional GI and Motility Disorders, University of North Carolina, and the Chair of the Rome Committee. "As a result, lubiprostone may represent an important treatment for IBS-C sufferers."
IBS is a condition that affects approximately 58 million Americans and accounts for 25-50 percent of referrals to gastroenterologists. IBS-C symptoms include abdominal pain or discomfort associated with defecation or a change in bowel habits with features of disordered defecation.
Lubiprostone 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. Lubiprostone is marketed in the U.S. as AMITIZA, a 24-mcg gelcap that was approved for use for chronic idiopathic constipation in adults on January 31, 2006.
Sucampo Pharmaceuticals expects to submit a supplemental New Drug Application for IBS-C to the U.S. Food and Drug Administration by July 2007.
About the Study for IBS-C (lubiprostone 8 mcg)
In two phase III, multi-center, double-blind, randomized, placebo-controlled trials, 1,171 adults diagnosed with IBS-C (Rome II Criteria) were enrolled and received lubiprostone 8 mcg taken twice daily (783 adults) or placebo (388 adults) over a 12-week period.
Primary efficacy was determined by a unique question: "How would you rate your relief of IBS symptoms (abdominal discomfort/pain, bowel habits and other IBS symptoms) over the past week compared to how you felt before you entered the study"" A 7-point balanced scale with a strict evaluation using the two highest scale points to qualify as a responder was used. Patients were considered monthly responders if they reported at least moderate relief four out of four weeks or significant relief two out of four weeks. To qualify as an overall responder (the measure used in the primary endpoint), patients had to be a monthly responder for at least two out of three months. During the evaluation period, patients discontinuing for any reason or reporting an increase in rescue medication use, lack of efficacy or moderately or significantly worse relief were deemed non-responders. These responder rates may not be comparable to those in other studies since the new scale was more restrictive than those used in previous reports.
The findings demonstrated that patients receiving lubiprostone 8 mcg twice daily were nearly twice as likely to achieve overall response compared to those receiving placebo (lubiprostone 17.9 percent vs. placebo 10.1 percent, P=0.001). There was a similar incidence of serious adverse events (1 percent in each group) and related adverse events (lubiprostone 22 percent vs. placebo 21 percent) compared to placebo. The most common treatment-related adverse events (>5% of patients) were nausea (8 percent vs. 4 percent, respectively), diarrhea (6 percent vs. 4 percent, respectively) and abdominal pain (4 percent vs. 5 percent, respectively).
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a chronic disorder characterized by abdominal discomfort and pain, and bowel habit changes including symptoms of 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 include IBS with constipation (IBS-C), with diarrhea (IBS-D) and with mixed symptoms of constipation and diarrhea (IBS-M). In IBS-C, symptoms are present for at least 3 days per month over a 3-month period. Although people with IBS-C report suffering from many of the same symptoms associated with constipation, the presence of abdominal discomfort and pain is what differentiates IBS-C from chronic constipation. Additionally, the hypersensitivity of the gastrointestinal system of individuals with IBS makes them more prone to experience the effects of even mild symptoms of constipation or diarrhea. 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.
About AMITIZA® (lubiprostone) 24 mcg BID for 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 for Chronic Idiopathic Constipation (24 mcg BID), the most common adverse event was nausea (31%). Other adverse events (=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.
AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., is an emerging pharmaceutical company based in Bethesda, Md. Sucampo Pharmaceuticals was founded in 1996 by Sachiko Kuno, Ph.D., the company's President and Chair of the Board of Directors, and Ryuji Ueno, M.D., Ph.D., Ph.D., the company's Chief Executive Officer and Chief Scientific Officer. Sucampo Pharmaceuticals focuses on the development and commercialization of drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. The therapeutic potential of prostones was first identified by Dr. Ueno. In January 2006, Sucampo Pharmaceuticals received marketing approval from the FDA for its first product, AMITIZA, for the treatment of Chronic Idiopathic Constipation in adults. In October 2004, Sucampo Pharmaceuticals entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market AMITIZA in the United States and Canada. Sucampo Pharmaceuticals' specialized sales force complements the efforts of Takeda by focusing on institutional and long-term care facilities. To learn more about the company and its products, visit www.sucampo.com.
Takeda Pharmaceuticals North America, Inc.
Based in Deerfield, 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 products for diabetes, insomnia, wakefulness and gastroenterology. The company 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
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 (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19-24, 2007, at the Washington Convention Center, Washington, DC. 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.