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# FDA Cancels Panel Meeting on Schizophrenia NDA
- URL: https://www.fdaweb.com/fda-cancels-panel-meeting-on-schizophrenia-nda/
- Published: 2019-07-24T12:00:00.000Z
- Updated: 2026-09-15T01:40:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144603

FDA has canceled a 7/31 meeting of its Psychopharmacologic Drugs Advisory Committee meeting that was scheduled to review an Intra-Cellular Therapies NDA for lumateperone tosylate capsules for treating schizophrenia. The company says the panel meeting was canceled to give FDA reviewers time to review FDA-requested additional information related to non-clinical studies and to allow sufficient time to review any forthcoming information as they continue the NDA review. The information review may result in an extension of the 9/27 user fee review action target date.

Lumateperone is described by Intra-Cellular as a molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate — three neurotransmitter pathways implicated in severe mental illness. It is a “potent serotonin 5-HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM) acting as a presynaptic partial agonist and postsynaptic antagonist at dopamine D2 receptors, a dopamine D1 receptor-dependent indirect modulator of glutamate (both NDMA and AMPA), and a serotonin reuptake inhibitor,” the company says.