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Napo Announces Successful Clinical Results in Phase 2 Study of Crofelemer in Acute Adult Infectious Diarrhea
Date:4/10/2008

SOUTH SAN FRANCISCO, Calif., April 10 /PRNewswire/ -- Napo Pharmaceuticals, Inc., (LSE: NAPL and NAPU) is pleased to announce the positive results of a successfully completed Phase 2 trial for CRO-ID (crofelemer for the treatment of acute adult infectious diarrhea) conducted by its partner, Glenmark Pharmaceuticals Limited (BSE: Glenmark). The primary endpoints of the trial were stool weight, duration of diarrhea, stool frequency and stool consistency; additional endpoints followed include degree of patient dehydration and reduction in gastrointestinal index score.

The conclusions from the study were that treatment with crofelemer was well tolerated and resulted in statistically significant improvements in all the primary endpoints and statistically significant reduction in the additional endpoints as well. Overall clinical success was achieved in 79.1% of the evaluable patients receiving crofelemer compared to 28.2% of the evaluable patients receiving placebo.

There were no drug related adverse events associated with crofelemer.

The Phase 2 study was a randomized, parallel group, double-blind, placebo-controlled which enrolled 98 Indian adult male and female patients aged between 18 to 65 years with acute diarrhea defined as the occurrence of three or more unformed stools (soft or watery consistency) within the 24 hour period preceding entry into the study. Patients suffering from acute infectious diarrhea were dosed 250mg of crofelemer, QID (4 times per day) until recovery or for a maximum of three days. Details regarding the stool weight, stool frequency, stool consistency, duration of diarrhea, and other gastrointestinal symptoms were recorded by the investigators at baseline, and days 1, 2 and 3 of treatment. All patients had a scheduled follow-up visit 30 days after the end of the last dose.

In conclusion, adult Indian patients with infectious diarrhea treated with crofelemer showed a faster recovery with the first dose itsel
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SOURCE Napo Pharmaceuticals, Inc.
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