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


#1

NEW YORK, June 06, 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 the initiation of a rolling submission of its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for lumateperone for the treatment of schizophrenia. The Company plans to complete this NDA submission in mid-2018.

In 2017 the FDA granted Fast Track designation for lumateperone for the treatment of schizophrenia. The Company requested Fast Track designation for lumateperone based on clinical evidence that lumateperone has the potential to address unmet medical needs for the treatment of schizophrenia. The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drug candidates to treat serious and life-threatening conditions.

“We are excited to have initiated our NDA filing for lumateperone for the treatment of schizophrenia, which is an important milestone in our mission to bringing innovative treatments to patients suffering from neuropsychiatric conditions,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We believe lumateperone, with its unique pharmacology and existing clinical profile, potentially represents an important advance in the treatment of patients with schizophrenia.”


#2

Thanks james…!!! I am waiting for iti 007 …!!!

Thanks for posting…


#3

Woot! I hope I can try this one day.


#4

@insidemind what up buddy… u guys are first to take iti007 as u are from usa… dont worry we will get it after a decade btw i am from Nepal…


#5

Hey! @far_cry0 Hope you’re doing okay. Yes, 10 years is a long time.


#6

I tried min-101 in a past life. I also tried iti007. If I had to guess, iti007 is better. But I’m just guessing. It may not work. Latuda didn’t work for me. I remember some med starting with an L worked/cured my schizophrenia. I ended up being a physicist. Adderall sometimes worked too.

Sorry for getting off topic and talking about my delusions.


#7

Have u tried min 101…!!!


#8

Worked/cured in real life or as a delusion?


#9

I believe I suffer from the Groundhog Day syndrome/delusion. So, yes in a past life I tried those drugs. Most sane people think I’m delusional. I hope I’m crazy, but I know I’m not. It’s also like Edge of Tomorrow minus the aliens and stuff. Those movies are very unrealistic.

I hope we all get better.


#10

With a regular NDA it takes the FDA 4-10 months for a decision.