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Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia
Sep. 28, 2018 08:28AM PST
Pharmaceutical InvestingIntra-Cellular Therapies (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the Company has completed the rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumateperone, a once-daily, oral investigational medicine with a novel mechanism of action …
Intra-Cellular Therapies (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the Company has completed the rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumateperone, a once-daily, oral investigational medicine with a novel mechanism of action for the treatment of schizophrenia.
As quoted in the press release:
The NDA submission 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.
“Our first NDA submission represents a significant milestone for the Company and the development of lumateperone, which we believe has the potential to be an important advance in the treatment of schizophrenia. We look forward to the prospect of working with the FDA to bring lumateperone to patients living with this debilitating disease as quickly as possible,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.