NEW YORK, NY, USA I December 11, 2018 I 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 accepted for review its New Drug Application (NDA) for lumateperone, an investigational agent for the treatment of schizophrenia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 27, 2019.
“The FDA’s acceptance of our NDA submission for lumateperone for the treatment of schizophrenia represents an important milestone and brings us closer to offering a potential advance in the treatment of patients suffering from schizophrenia,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.
The lumateperone NDA for the treatment of schizophrenia is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received Fast Track designation from the FDA in November 2017 for the treatment of schizophrenia.
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 has the potential to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases.
About Intra-Cellular Therapies
Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson’s and Alzheimer’s disease. The Company is developing its lead drug candidate, lumateperone (also known as ITI-007), for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in patients with dementia, including Alzheimer’s disease, depression and other neuropsychiatric and neurological disorders. Lumateperone is under review by the FDA for the treatment of schizophrenia and is in Phase 3 clinical development for the treatment of bipolar depression and agitation associated with dementia, including Alzheimer’s disease. The Company is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. The lead molecule in the Company’s PDE1 portfolio, ITI-214, is in development for the treatment of symptoms associated with Parkinson’s disease and for the treatment of heart failure.
SOURCE: Intra-Cellular Therapies
Post Views: 19
NEW YORK, NY, USA I December 11, 2018 I 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 accepted for review its New Drug Application (NDA) for lumateperone, an investigational agent for the treatment of schizophrenia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 27, 2019.
“The FDA’s acceptance of our NDA submission for lumateperone for the treatment of schizophrenia represents an important milestone and brings us closer to offering a potential advance in the treatment of patients suffering from schizophrenia,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.
The lumateperone NDA for the treatment of schizophrenia is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received Fast Track designation from the FDA in November 2017 for the treatment of schizophrenia.
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 has the potential to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases.
About Intra-Cellular Therapies
Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson’s and Alzheimer’s disease. The Company is developing its lead drug candidate, lumateperone (also known as ITI-007), for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in patients with dementia, including Alzheimer’s disease, depression and other neuropsychiatric and neurological disorders. Lumateperone is under review by the FDA for the treatment of schizophrenia and is in Phase 3 clinical development for the treatment of bipolar depression and agitation associated with dementia, including Alzheimer’s disease. The Company is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. The lead molecule in the Company’s PDE1 portfolio, ITI-214, is in development for the treatment of symptoms associated with Parkinson’s disease and for the treatment of heart failure.
SOURCE: Intra-Cellular Therapies
Post Views: 19
