( ced stoolfrequency. Treatment benefits...)Phase 2a Diarrhea Predominant Irritable Bowel Syndrome Results from,2006 Presented at Digestive Disease Week in Washington, D.C.,Health

As with previous trials of crofelemer, no drug-related serious adverse events were reported. Adverse event rates were similar across all dose groups, although in the two highest doses (250 and 500 mg bid) there were a higher percentage of dropouts. There were no drug-related or dose-related differences in constipation. During the two-week treatment free follow-up period symptoms approached baseline levels.

    Conclusion: Crofelemer, 125 mg bid, was safe and led to significant

improvement in pain, and trends toward improvement in adequate relief, stool

frequency and urgency.




    Endpoint                Results(1)                 p-value


                           (difference from Placebo)


    Pain score              -0.42*                     0.02

    Frequency               -0.7                       0.13

    (stools/day)

    Consistency Score       -0.03                      0.70

    Urgency Free days       +11.2%                     0.20

    Adequate Relief         +16%                       0.43



    (1) Month 3 results (end of the three month treatment period); observed

        case analysis with disease outliers (mean baseline frequency >9

        stools/day) removed from all groups.


    *statistically significant at p<0.05

Lisa A. Conte, Napo's CEO commented: "The results of this trial using 125 mg bid of crofelemer, in addition to supportive pre-clinical data, was the impetus for our decision to incorporate this dosage in our adaptive design for the CRO-HIV trial. As we've said before, we were very encouraged by the study results, especially for pain, and look forward to the data from the ongoing Phase 2b trial. And, as has been seen in all previous studies of crofelemer, there were no adverse safety events reported."

    For more information please contact:


    Napo Ph
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