NDA Submitted for Novel Schizophrenia Treatment Lumateperone
The treatment received the FDA's Fast Track designation.
Intra-Cellular Therapies has submitted its New Drug Application (NDA) for lumateperone, a once-daily, oral investigational medicine for the treatment of schizophrenia.
Lumateperone, a first-in-class molecule, works via potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation. It also acts as a pre-synaptic partial agonist and post-synaptic antagonist at D2 receptors. The Company states that the NDA submission includes data from 20 clinical trials involving more than 1900 individuals exposed to lumateperone.
"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.
In addition to schizophrenia, Intra-Cellular Therapeutics is also developing lumateperone for the treatment of bipolar disorder, agitation associated with dementia, including Alzheimer's disease, and other neuropsychiatric and neurological disorders.
For more information visit Intracellulartherapies.com.