Dopamine hypothesis of schizophrenia

Neurocrine Biosciences Announces Top-Line Results from Phase II INTERACT Study Evaluating Luvadaxistat (NBI-1065844) for the Treatment of Negative Symptoms and Cognitive Impairment Associated with Schizophrenia (CIAS)

Retrieved on: 
Tuesday, March 2, 2021

The results from the Phase II INTERACT study are being evaluated to determine next steps for development activities.

Key Points: 
  • The results from the Phase II INTERACT study are being evaluated to determine next steps for development activities.
  • "The Phase II INTERACT study was a well-designed and executed clinical study that resulted in a negative outcome for luvadaxistat on the primary endpoint assessing the change from baseline in negative symptoms of schizophrenia.
  • "The totality of the top-line data from this study therefore support further clinical evaluation of luvadaxistat.
  • These approaches do not impact the negative symptoms of schizophrenia or cognitive impairment associated with schizophrenia (CIAS), suggesting that dysfunction of the dopamine system might not fully explain the negative and cognitive symptoms associated with schizophrenia.

Intra-Cellular Therapies Provides Lumateperone Regulatory Update

Retrieved on: 
Tuesday, September 10, 2019

The lumateperone Prescription Drug User Fee Act (PDUFA) goal date isDecember 27, 2019.

Key Points: 
  • The lumateperone Prescription Drug User Fee Act (PDUFA) goal date isDecember 27, 2019.
  • There is an ongoing unmet need for new treatments for schizophrenia and we look forward to continuing our work with the FDA to bring lumateperone to patients.
  • Lumateperone, our lead product candidate, is a molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate - three neurotransmitter pathways implicated in severe mental illness.
  • Lumateperone is an investigational new drug and has not been approved for marketing for any use by theFDA or any other regulatory authority in any other jurisdiction.