FDA clears Cerecor’s FP01 IND for treatment of cough

Cerecor Inc., a biopharmaceutical company focused on the discovery, development and commercialization of prescription pharmaceuticals whose primary activity is in the human nervous system, today announced that its Investigational New Drug (IND) Application for FP01 for the treatment of cough has cleared the 30 day deliberation period by the U.S. Food and Drug Administration (FDA).  The Company plans to immediately characterize the pharmacokinetics of FP01 lozenges in humans and thereafter to initiate an exploratory Phase II acute cough study in healthy subjects with upper respiratory tract infections (URTI).                     

"Acceptance by the FDA of this application and the advancement of FP01 to clinical testing are important milestones for the Company and key steps along the path to commercialize a treatment for acute and chronic cough. 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 Dr. Blake Paterson, CEO and co-founder of Cerecor.