Intra-Cellular NDA Accepted for Schizophrenia Drug

FDA has accepted an Intra-Cellular Therapies NDA for lumateperone, an investigational agent for treating schizophrenia. The submission is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone, which received an FDA fast track designation 11/2017. The agency has set a user fee review target action date of 9/27/2019.

The company describes lumateperone 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, and a serotonin reuptake inhibitor,” Intra-Cellular says.