Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia

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NEW YORK, Sept. 28, 2018 (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 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. 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. http://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-completes-submission-new-drug

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The FDA should announce a decision date deadline as a result. The decision date deadline is often 4-9 months later.

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What do you mean, like accept the NDA, or a release date for the medication?

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What type of med is this?

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It is a medicine that does not directly block dopamine receptors. It is supposed to avoid the worst side effects of current meds, and not cause weight gain, blood sugar problems, prolactin increases, or movement disorders.

That is not to say it will be free of side effects, but they may not be as serious health wise.

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I hope it works out for people.

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First the FDA announces they have accepted the NDA for review. They may issue a date for approval or disapproval maybe 9 months from now, for example.
Often the FDA decides yes or no before the target decision date.

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