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Irritable Bowel Syndrome: Patients
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Ocera ... recently announced the initiation of Phase 2 trials with AST-120 in Irritable Bowel Syndrome and Hepatic Encephalopathy. AST-120 is an oral agent known to adsorb bile acids, toxins and mediators of inflammation from the gastrointestinal tract with the potential to address multiple gastrointestinal diseases. Ocera in-licensed AST-120 from Kureha Corporation based in Tokyo, Japan. AST-120 is not absorbed in the gut and is marketed in Japan and Korea for chronic kidney disease, where it has been used in more than 200,000 patients.
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Irritable bowel syndrome (IBS) is defined as chronic or recurrent abdominal pain, altered bowel habits, and bloating, with the absence of structural or biochemical abnormalities to explain these symptoms. IBS is part of a broader group of disorders known as functional gastrointestinal disorders. It is the most common gastrointestinal diagnosis among gastroenterology practices in the United States and is one of the top 10 reasons for visits to primary care physicians. IBS is recognized in children, and many patients trace the onset of their symptoms to childhood. Children who have a history of recurrent abdominal pain are at increased risk of IBS during adolescence and young adulthood.
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The restructuring will have no effect on the Company's late-stage clinical development program with dextofisopam, which is currently in Phase 2b testing in the U.S. as a treatment for irritable bowel syndrome (IBS). The double-blinded study, which commenced in June 2007, is designed to enroll approximately 480 patients with data expected in 2009. Dextofisopam completed a successful Phase 2a IBS study in which it demonstrated a statistically significant improvement over placebo on the primary endpoint of adequate overall relief (n=141, p=0.033), and was very well tolerated. IBS affects roughly 10%-15% of U.S. adults and with a void of safe and effective available therapies represents a large, underserved market. Dextofisopam's novel non-serotonergic brain-gut mechanism holds the potential for a unique and innovative IBS treatment approach.
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In addition to the Cure Irritable Bowel book series, you'll ... receive a study of 1,569 patients with IBS, done in six different surveys, that shows the dramatic improvement the subjects reported. This miracle cure was discovered by accident and is now a primary treatment against IBS in Europe. Here is a sample of the study results . . .
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The irritable bowel syndrome (IBS) is a highly prevalent disorder (Talley et al., 1991). The role of motility and sensory dysfunction in IBS and a growing understanding of the roles of neurotransmitters and hormones in the control of gastrointestinal (GI) motility and secretion and sensation (Goyal & Hirano, 1996; Cooke, 2000; Grundy, 2002) provide a basis for more effective therapies. Why has this burgeoning science not been translated to clinical effectiveness and impact of the novel therapies? The objectives of this article are: to provide a review of the challenges facing academic and clinical gastroenterologists engaged in the management of patients with the irritable bowel syndrome (Drossman et al., 2002) and to look to the future for new therapies to build on the successes represented by the approval and introduction to patient care of two serotonergic agents, alosetron and tegaserod.
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There are several new medications for treatment of irritable bowel syndrome and related functional GI disorders, and, pending final approval by FDA, may soon offer new treatment options and potentially improved outcomes for some IBS patients. If you suffer from IBS and have not achieved successful results with medications currently available, consult with your physician so that the possibility of improved results with a newer medication can be evaluated. As of this writing, the following medications are available and typically used in treatment of IBS.
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