NEW YORK, June 13, 2019 (GLOBE NEWSWIRE) – Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has announced a Psychopharmacologic Drugs Advisory Committee meeting to be held on July 31, 2019 to discuss the New Drug Application (NDA) for lumateperone with the proposed indication of treatment of schizophrenia in adults. Lumateperone is a novel investigational drug with an NDA currently under review by FDA as a treatment of schizophrenia in adults.
FDA’s expected Prescription Drug User Fee Act (PDUFA) action date is September 27, 2019.
“There remains a significant unmet medical need in the treatment of schizophrenia,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We welcome the opportunity to present our data at the Advisory Committee meeting as we continue working to bring lumateperone to patients living with this debilitating disease.”
About Lumateperone for the Treatment of Schizophrenia
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 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. This compound is being investigated in patients suffering from a range of neuropsychiatric and neurodegenerative diseases.