FDA clears Cerecor’s FP01
Wednesday, April 11, 2012
Baltimore-based biopharmaceutical company Cerecor’s Investigational New Drug (IND) application for FP01 for the treatment of cough has cleared the 30 day deliberation period by the FDA.
The company plans to immediately characterize the pharmacokinetics of FP01 lozenges in humans and thereafter initiate an exploratory phase II acute cough study in healthy subjects with upper respiratory tract infections (URTI).
“The data we plan to generate from the initial phase II study will educate us about the effect size of FP01 as an antitussive, providing for future studies,” said Blake Paterson, CEO and co-founder of Cerecor.