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Phase 2a Diarrhea Predominant Irritable Bowel Syndrome Results from,2006 Presented at Digestive Disease Week in Washington, D.C.

SOUTH SAN FRANCISCO, Calif., May 23, 2007 /PRNewswire-FirstCall/ -- Napo Pharmaceuticals, Inc., , which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners, announced that Trine Pharmaceuticals, Inc. ("Trine") is presenting a poster detailing the results of a Phase 2a study conducted in 2006 for crofelemer for diarrhoea predominant irritable bowel syndrome (d-IBS) today at Digestive Disease Week in Washington, D.C. Trine licensed crofelemer for the d-IBS indication from Napo in June 2004. Trine has worldwide development and commercialization rights to crofelemer for d-IBS. The objective of the trial was to evaluate the safety and efficacy of crofelemer in men and women with d-IBS.

The trial was designed as a randomized double-blind placebo-controlled, dose-ranging (placebo, 125 mg, 250 mg, and 500 mg bid) study over a 12-week treatment period in 246 patients with d-IBS (Rome II criteria), including both males and females, whose average age was 50 years old.

IBS symptoms (pain, urgency, stool frequency and consistency, and adequate relief) were self-reported by the patients via an interactive voice response system (IVRS). Patients needed to exhibit active disease during the two-week baseline period as defined by a mean daily stool frequency greater than or equal to 2/day, pain score greater than or equal to 1 and stool consistency greater than or equal to 3 (5-point Lickert scale for pain and consistency) to be enrolled. Patients received treatment for 12 weeks followed by a two-week treatment free period.

Results: The 125 mg bid of crofelemer exhibited a consistent response during each month among most efficacy endpoints in women with d-IBS (see table) reaching statistical significance (p<0.05) for pain. Crofelemer had little effect on the stool consistency score, though there was a trend toward redu
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