The randomised, placebo-controlled, multi-centre study was conducted by Glenmark Pharmaceuticals, the partner of Napo Pharmaceuticals.
The study 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 had 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 this indication in the mid-year and the company has received fast track designation by the FDA for the drug.