Intra-Cellular Therapies Announces Positive Pre-NDA Meeting with FDA for Lumateperone for the Treatment of Schizophrenia
NEW YORK, March 13, 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 had a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding lumateperone for the treatment of schizophrenia. At the meeting, the Company and the FDA agreed on the proposed content and timing of a rolling NDA submission. As previously announced, the Company plans to complete its NDA submission by 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 pleased with the outcome of our pre-NDA meeting and look forward to initiating our rolling NDA submission. We have made significant progress in the advancement of lumateperone and our mission to provide better treatment options for patients suffering from neuropsychiatric conditions,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies