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.”