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Napo Announces Positive Clinical Data Indicating Crofelemer, Could Effectively Treat Cholera
Date:9/22/2008

SAN FRANCISCO, Sept. 22 /PRNewswire/ -- Napo Pharmaceuticals (LSE: NAPL/NAPU) today announces positive clinical data on the effectiveness of crofelemer from a study for CRO-ID in treating severely ill cholera patients in conjunction with an antibiotic and rehydration therapy.

A double-blind placebo-controlled study was conducted in one hundred (100) patients with confirmed severe cholera. Patients were randomized to placebo or 125 mg crofelemer every 6 hours or 250 mg crofelemer every 6 hours in a 1:2:2 randomization scheme. This single center trial was conducted at the International Centre for Diarrhoeal Disease Research (ICDDR, B) in Dhaka, Bangladesh, popularly known as the "cholera hospital" for the state-of-the-art treatment of cholera patients.

The purpose of the trial was to obtain a therapeutic proof-of-concept in the treatment of cholera, by a reduction in the life-threatening fluid loss characteristic of cholera infection. In addition to receiving crofelemer, all patients received a single oral dose of azithromycin and rehydration therapy. These severely ill cholera patients, even when receiving the antibiotic azithromycin and rehydration therapy (but not crofelemer), averaged approximately 8.5 liters of stool volume output during the first 24 hour period. The primary endpoint in this study was the reduction in stool volume output normalized to the body weight of the cholera patients.

Following the exclusion of three outlier patients, the data demonstrates that a crofelemer dose of 125 mg every 6 hours reduced the amount of stool volume output normalized to body weight by 32% (p=0.028, Mann-Whitney test) in the first 6 hour period (0-6 hours). A 31% reduction in normalized stool volume output was also observed during the first 12 hour period (0-12 hours) with crofelemer 125 mg every 6 hours (p=0.072, Mann-Whitney test). The higher dose of crofelemer (250 mg every 6 hours) also showed a trend towards significance in the first 12
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SOURCE Napo Pharmaceuticals, Inc.
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