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.