The designation will allow frequent interactions with the FDA during the drug development process, which assures that questions and issues are resolved quickly.
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) among nerve cells.
Neurocrine chief medical officer Christopher O’Brien said the FDA’s fast track designation recognizes the significant need for an effective treatment for tardive dyskinesia.