FDA clears Cerecor’s FP01

Wednesday, April 11, 2012 04:04 PM

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.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs