FDA approval for the new drug came yesterday. CEO Kevin Gorman of Neurocrine Biosciences (NBIX) revealed the plan for the development of this drug in 2014 in an exclusive interview with the Wall Street Transcript:
“For example, maybe the physician can lower the dose of antipsychotic that the patient is on while the patient is taking this drug for tardive dyskinesia. So it actually could be a new and novel treatment for schizophrenia. That’s beyond our reach right now.
Schizophrenia trials are complex and large, and so while we enjoy a long patent protection on composition of matter with that drug, what we are currently concentrating on is to get the drug filed in TD in 2016 and approved in 2017. Then, as long as the data package is sufficient for the FDA, about a year to a year and a half following that, we could receive approval for Tourette syndrome.
At that point in time, we can really start entertaining whether we are going to develop that into the actual indication of schizophrenia. So that’s just all upside for the drug at that point.”
Neurocrine Biosciences, Inc. (NBIX) Endometriosis Drug in Phase III
September 29, 2014