Newswise — New study results indicated that treatment with AMITIZA® (lubiprostone) 8 mcg lead to significant relief of overall symptoms of Irritable Bowel Syndrome with Constipation (IBS-C). These results were presented at Digestive Disease Week (DDW) 2008, the largest annual international meeting of digestive disease specialists.
"IBS-C is a multi-symptom disorder and is one of the most common conditions seen by gastroenterologists," said William D. Chey, M.D., primary investigator of the study, University of Michigan Health System. "These data are important because they show that in studies, AMITIZA has demonstrated the ability to improve the overall symptoms reported by patients with IBS-C."
AMITIZA 8 mcg was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2008 for the treatment of IBS-C in women 18 years of age and older, and has been approved since 2006 at a 24 mcg dose for the treatment of Chronic Idiopathic Constipation in adults. These data were among others presented at DDW 2008 that evaluated the effect of AMITIZA for IBS-C.
"AMITIZA is the first ClC-2 channel activator and the only widely available FDA-approved agent for the treatment of IBS-C in adult women in the United States. AMITIZA could provide overall symptom relief for the millions of appropriate patients in the U.S. who suffer from this condition," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer, Sucampo Pharmaceuticals (NASDAQ: SCMP). "We are pleased with the body of data on AMITIZA presented at DDW this year. Additional data presented at this meeting may help physicians better understand how to treat their patients with IBS-C."
"AMITIZA makes it possible for appropriate patients to receive a widely available FDA-approved treatment for their IBS-C," said Charles Baum, M.D., gastroenterologist and executive medical director, Gastroenterology and Internal Medicine, Takeda Pharmaceuticals North America, Inc.
Approximately 58 million Americans have Irritable Bowel Syndrome (IBS), and IBS-C accounts for approximately one-third of these cases. IBS-C is a chronic disorder characterized by abdominal discomfort or pain and changes in bowel habits including symptoms of constipation.
AMITIZA was developed by Sucampo Pharmaceuticals and is co-marketed in the U.S. by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America.
About Irritable Bowel Syndrome with Constipation (IBS-C) IBS is a disorder characterized by symptoms including recurrent abdominal discomfort or pain, bloating, and changes of bowel habits such as constipation and/or diarrhea. There are three main types of IBS: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and IBS with mixed constipation and diarrhea (IBS-M). In IBS-C, symptoms are present for at least 12 weeks (not necessarily consecutive) over a 12-month period. Although people with IBS-C report many of the symptoms associated with constipation, the presence of abdominal discomfort or pain is what differentiates IBS-C from chronic constipation. IBS is approximately two to two-and-a-half times more prevalent in women than men.
Additional data being presented at DDW
Clinical Data:Abstract #157; Oral; Sunday, May 18, 2008 at 3:00pm PDTWhat Symptoms Drive Global Symptom Improvement with Lubiprostone in Patients with Irritable Bowel Syndrome and Constipation: Data from Two Multicenter, Randomized, Placebo-controlled Trials
Abstract #S1272; Poster; Sunday, May 18, 2008 from 8am-5pm PDT; Poster presentation from 12pm-2pmLubiprostone is Effective and Well Tolerated Through 48 Weeks of Treatment in Adults with Irritable Bowel Syndrome and Constipation
Abstract #T1036; Poster; Tuesday, May 20, 2008 from 8am-5pm PDT; Poster presentation from 12pm-2pmHealth-Related Quality of Life in Adults with Irritable Bowel Syndrome with Constipation: Results of a Combined Analysis of Two Phase 3 Studies with Lubiprostone
Abstract #M1706; Poster; Monday, May 19, 2008 from 8am-5pm PDT; Poster presentation from 12pm-2pmDiscontinuation of Lubiprostone Treatment for Irritable Bowel Syndrome with Constipation is Not Associated with Symptom Increase or Recurrence: Results from a randomized withdrawal study
Outcomes Data:Abstract #T1029; Poster; Tuesday, May 20, 2008 from 8am-5pm PDT; Poster presentation from 12pm-2pm PDTDevelopment of an Instrument to Assess Treatment Satisfaction in Patients with Chronic Constipation
Abstract #T1030; Poster; Tuesday, May 20, 2008 from 8am-5pm PDT; Poster presentation from 12pm-2pm PDTSimilarities between Constipation with and without Irritable Bowel Syndrome in a California Medicaid (Medi-Cal) population: Costs trends by category in the 12 months after diagnosis from 1997 to 2002
Abstract #808; Oral; Tuesday, May 20, 2008 from 4pm-5:30pm PDT; Presentation from 4:30pm-4:45pm PDTDirect Medical Costs Associated with Constipation from Childhood to Early Adulthood: A Birth Cohort Study
Pre-Clinical Data:Abstract #T1876; Poster; Tuesday, May 20, 2008 from 8am-5pm PDT; Poster presentation from 12pm-2pm PDTLubiprostone Activation of Cl- Currents Does Not Involve Ca2+, cAMP, or PKA
Abstract #T1877; Poster; Tuesday, May 20, 2008 from 8am-5pm PDT; Poster presentation from 12pm-2pm PDTClC-2-Targeted siRNA Eliminates Lubiprostone Activation of Cl- Currents in T84 Cells
Abstract #T1081; Poster; Tuesday, May 20, 2008 from 8am-5pm PDT; Poster presentation from 12pm-2pm PDTEffect of Lubiprostone on Duodenal Mucosal Bicarbonate Secretion
Abstract #844; Oral; Tuesday, May 20, 2008 from 4pm-5:30pm PDT; Presentation from 4:45pm-5pm PDTLubiprostone Reverses the Inhibitory Action of Morphine on Mucosal Secretion in the Human Jejunum
Abstract #T1380; Poster; Tuesday, May 20, 2008 from 8am-5pm PDT; Poster presentation from 12pm-2pm PDT Lubiprostone Enhances Histamine H2 Receptor-Mediated Cyclical Chloride Secretion in the Guinea Pig Colon
About AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation and IBS-C IndicationAMITIZA® (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg) in women > 18 years old.
Important Safety InformationAMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating physician to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans. 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.
Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their physician.
AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their physician if the diarrhea becomes severe.
Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their physician.
In clinical trials of AMITIZA (24 mcg) in patients with Chronic Idiopathic Constipation, the most common adverse reactions (incidence > 4%) were nausea (29%), diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distention (6%), and flatulence (6%).
In clinical trials of AMITIZA (8 mcg) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence > 4%) were nausea (8%), diarrhea (7%), and abdominal pain (5%).
Please see complete Prescribing Information at www.amitiza.com.
AMITIZA is co-marketed by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc.
AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, Md., focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' chairman and chief executive officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding chief executive officer and advisor, international business development.
Sucampo Pharmaceuticals is marketing AMITIZA® (lubiprostone) in the U.S. for Chronic Idiopathic Constipation in adults and Irritable Bowel Syndrome with Constipation in women 18 years of age and older and is developing the drug for additional gastrointestinal disorders with large potential markets. In addition, Sucampo Pharmaceuticals has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly-owned subsidiaries: Sucampo Pharma Europe, Ltd., headquartered in Oxford, UK with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd., located in Tokyo and Osaka, Japan. To learn more about Sucampo Pharmaceuticals 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, TPNA 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. TPNA 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)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 17-22, 2008, at the San Diego Convention Center, San Diego, CA. 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 http://www.ddw.org.
RSS