« Return to archives | Clinical Intelligence

FDA grants Fast Track designation to Neurocrine Biosciences

Thursday, January 26, 2012 10:17 AM

The FDA has granted Neurocrine Biosciences Fast Track designation for its VMAT2 inhibitor product candidate NBI-98854, for the treatment of neuroleptic-induced tardive dyskinesia.

The Fast Track program allows more frequent interactions with the FDA during the drug development process, assuring questions and issues are resolved quickly and often leading to earlier drug approval and access by patients.

"The FDA's Fast Track designation recognizes the significant need for an effective treatment for tardive dyskinesia," said Christopher F. O'Brien, M.D., chief medical officer of Neurocrine Biosciences.

NBI-98854 aims to treat tardive dyskinesia—a condition characterized by involuntary, repetitive movements of the extremities—by modulating dopamine release during nerve communication. At the same time, it will have minimal impact on the other monoamines, thereby reducing the likelihood of "off target" side effects. NBI-98854 is designed to provide low, sustained plasma and brain concentrations of active drug to minimize side effects associated with excessive dopamine depletion.

NBI-98854 may also be useful in other disorders, such as Huntington's chorea, schizophrenia, Tourette's syndrome and tardive dystonia.

Share:          
CWWeekly

February 21

Survey: Sponsors, CROs making changes to their business models to demonstrate value to payers

Cegedim ranks top pharma companies on their use of, and success with, social media

To read the full articles for this issue of CWWeekly, please click here for subscription information.

Already a digital subscriber? Access this issue now.

CWWeekly

February

Anticipating the rise of virtual drug development
With the rising cost of drug development and a continued shortage of new products entering the marketplace, the virtual pharma model is expected to become more prevalent going forward, particularly as pharma companies have...

Closing investigative site operations a complex process
In light of the shrinking investigative site landscape, CenterWatch has conducted in-depth case studies of sites closing their operations. Site personnel offer insights into...

Eye On Shire
Shire is a rapidly growing, global specialty biopharmaceutical company, directly marketing its products in over 50 countries...

To read the full articles for this issue of The CenterWatch Monthly, please click here for subscription information.

Already a digital subscriber? Access this issue now.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

Copyright © 1995-2012 CenterWatch.