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Tioga Pharmaceuticals' Asimadoline Demonstrates Positive Results in a Phase 2b Clinical Trial for the Treatment of Irritable Bowel Syndrome
Date:5/20/2008

ed. Patients underwent a two-week screening, a 12-week treatment and a four-week follow-up period, and they received identical appearing placebo, 0.15 mg, 0.5 mg or 1.0 mg tablets of asimadoline twice daily for the treatment period. Throughout the trial, patients entered data daily by IVRS (interactive voice response system). The primary endpoint was number of months a patient was a responder for adequate relief of pain, where the primary measure was the question, "In the past 7 days have you had adequate relief of your IBS pain or discomfort?" asked once every 7 days. A monthly responder replied "yes" at least three weeks per month. The secondary endpoints were abdominal pain, stool frequency and consistency, urgency, bloating, adequate relief of IBS symptoms and straining. Secondary endpoints were also collected using IVRS. Adverse events, labs and echocardiograms were also collected.

About Irritable Bowel Syndrome

Irritable bowel syndrome is a common, chronic gastrointestinal disorder characterized by abdominal pain and discomfort associated with alterations in bowel habits. The bowel abnormalities may manifest as diarrhea-predominant disease, constipation-predominant disease, or alternation between diarrhea and constipation. IBS is estimated to afflict approximately 12 percent of the adult population in the United States and Europe, with roughly equal prevalence of each subtype. For reasons that remain unknown, IBS is a female-predominant disorder, with two-thirds to three-quarters of the subjects being female.

Lotronex (alosetron), a selective 5-HT3 receptor antagonist, is the only drug currently approved by the FDA for the treatment of D-IBS; however, due to safety concerns, Lotronex was removed from the market in 2001 and re-launched in 2002 under a strict risk management program. No treatment is currently approved by the FDA for A-IBS. There is, therefore, an urgent unmet clinical need for a safe and effective treatment for the 20 millio
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SOURCE Tioga Pharmaceuticals, Inc.
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