Schizophrenia Spectrum and Psychotic Disorders

FDA to Review Lumateperone for Treatment of Schizophrenia

DaHee Han, PharmD
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schizophrenia
Lumateperone and follow-on compounds are also being evaluated for bipolar depression, behavioral disturbance associated with dementia, sleep disturbances associated with neuropsychiatric disorders, and other neuropsychiatric conditions including major depressive disorder and autism.

Intra-Cellular Therapies announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lumateperone (ITI-007) for the treatment of schizophrenia. 

Lumateperone, a first-in-class molecule, 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 NDA submission includes data from 20 trials involving >1900 patients.

Lumateperone and follow-on compounds are also being evaluated for bipolar depression, behavioral disturbances associated with dementia, sleep disturbances associated with neuropsychiatric disorders, and other neuropsychiatric conditions including major depressive disorder and autism. 

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The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of September 27, 2019. 

For more information call (646) 440-9333 or visit IntracellularTherapies.com.

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This article originally appeared on MPR