Napo Pharmaceuticals has reported positive results from a Phase II study of crofelemer as a treatment of hospitalised adults with mild to moderate acute watery diarrhoea.
The randomised, placebo-controlled, multi-centre study was conducted by Glenmark Pharmaceuticals, Napo Pharmaceuticals’ partner.
The results showed that patients receiving crofelemer had significantly higher resolution of diarrhoea compared to those receiving placebo.
Crofelemer was found to be safe, and no apparent differences in adverse events were found in patients treated with crofelemer when compared to those treated with placebo.
In November 2010, Napo released statistically significant results of a Phase III study of crofelemer for treatment of chronic diarrhoea in people living with HIV/AIDS on anti-retroviral therapy.
Napo will file a new drug application for crofelemer for the indication in the middle of the year. The company has received fast-track designation from the FDA for the drug.
