Napo to commence Ph II Indian crofelemer trial
The USA's Napo Pharmaceuticals has received approval from the Drug Controller General of India to start a Phase II trial with crofelemer, its proprietary gastrointestinal compound for the treatment of acute infectious diarrhea.
The trial will be initiated by Glenmark Pharmaceuticals, a research-led global pharmaceutical company headquartered in India, and Napo's product development and commercialization partner for the agent in India and more than 110 emerging and developing country economies for the indications of AIDS-related diarrhea, infectious diarrhea and pediatric diarrhea. Upon marketing, Glenmark will pay up to 14% royalties to Napo.
The trial is expected to commence in calendar 2006 and will involve 60 adult patients suffering from acute diarrhea in a prospective, randomized, parallel-group, double-blind, placebo-controlled evaluation.
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