Glenmark Pharma has received positive indications from the multi-centre study of crofelemer in acute watery diarrhoea in adult patients. In this multi-centre, placebo controlled trial, resolution of diarrhoea was significantly higher in the crofelemer arm compared to placebo. The clinical success rate was also greater in the crofelemer arm compared to placebo. Crofelemer was found to be safe with no apparent differences in adverse event profile in the crofelemer group compared to placebo.

Grlenn Saldanha, CEO & managing director, said, “The successful completion of this adult acute diarrhoea study is another piece of encouraging news for Glenmark, as crofelemer will potentially be the first NCE to be launched by the organisation. Glenmark will accelerate the development of crofelemer  in the acute indication including paediatric diarrhoea where several million individuals are affected in he geographies that we operate in.”

This trial in mild to moderate adult patients with acute watery diarrhoea was the second proof of concept study conducted by Glenmark with crofelemer. Adult patients with mild to moderate diarrhoea were dosed with crofelemer over a period for 3 days with a follow-up period of 30 days. This was a 3 arm drug vs placebo study which included a 125 mg, 250 mg and 500 mg dose of crofelemer. Overall crofelemer showed superiority to the placebo arm.

In November 2010, Glenmark along with its partners, Napo Pharmaceuticals and Salix Pharmaceuticals, announced the successful completion of phase III trials with crofelemer for the treatment of diarrhoea in patients with HIV in the USA. Crofelemer is licensed to Glenmark from Napo Pharmaceuticals. Glenmark has the exclusive license to develop, commercialise and distribute crofelemer in 140 emerging countries for indication related to HIV, use in acute adult and paediatric diarrhoea, including supply to NGOs for delivery with these countries. Glenmark and Salix have also entered into a commercial supply agreement for crofelemer active pharmaceutical ingredient (API).