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September 07, 2017 07:00 ET | Source: Intra-Cellular Therapies, Inc.
Intra-Cellular Therapies to Host a Conference Call Today at 8:30 a.m. ET
NEW YORK, Sept. 07, 2017 (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 positive topline data from the first part of an open-label safety switching study in which 302 patients with stable symptoms of schizophrenia were switched from standard-of-care antipsychotic medications to lumateperone (ITI-007 60 mg) with no dose titration of lumateperone required for a 6-week treatment duration, then switched back to standard-of-care.
https://globenewswire.com/news-release/2017/09/07/1113925/0/en/Intra-Cellular-Therapies-Announces-Positive-Topline-Data-From-6-Week-Open-label-Safety-Switching-Study-with-Lumateperone-in-Patients-with-Schizophrenia.html
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Good news…soon it will hit market …!!!
Open label means people know they are on ITI 007, so part of this could be placebo effect, but this is still very encouraging:
"Consistent with good clinical care, patients were tapered down from their previous antipsychotic medication during the screening period or switched to lumateperone from one day to the next if no tapering down of the previous antipsychotic medication was clinically indicated. In this study, the most recent antipsychotic taken prior to screening, in descending order of frequency, included risperidone, quetiapine, aripiprazole, olanzapine, lurasidone, ziprasidone, haloperidol, paliperidone, perphenazine, asenapine, brexpiprazole and iloperidone.
The most frequent drug-related adverse event was somnolence occurring in 6.6% of patients receiving ITI-007 60 mg dosed daily in the evening. The proportion of patients reporting somnolence in this study was lower than that observed with morning dosing in previous lumateperone controlled trials and similar to that seen with placebo in those studies. There were no drug related serious adverse events. The proportion of patients experiencing motor side effects on lumateperone was low: akathisia (0.3%), and extrapyramidal side effects (0.7%). There were no signs of emerging extrapyramidal side effects, akathisia or dyskinesia as measured by the SAS, BARS or AIMS, respectively."
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Which phase is it in … @twinklestars …!!!
It’s completed phase 3 but Intracellular has not yet submitted the new drug application to the FDA, which is the last step to selling the drug. They have said they will submit it in mid 2018. They will have more data then, like the long term safety study and the bipolar study.
After an application is submitted to the FDA it can take awhile for them to approve it, possibly a year to 2.5 years. So we might be looking at 2019 to 2021 for release if it meets with FDA approval.
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