We are developing NRL-4, a proprietary nasal spray formulation of olanzapine and Intravail®, for the treatment of acute agitation in patients with schizophrenia and bipolar disorder.* There are currently no outpatient rescue medications approved for the treatment of acute agitation. We believe that our portable nasal formulation of olanzapine for the treatment of acute agitation episodes may reduce emergency room visits for the three million schizophrenia and bipolar disorder patients in the United States. We expect to submit an investigational new drug application (IND) in the fourth quarter of 2021 and begin clinical trials in 2022.
*NRL-4 is a product candidate that has not been approved by the U.S. Food and Drug Administration for any indication.