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Acute agitation is associated with several psychiatric disorders, including schizophrenia and bipolar mania 1 in adults. Approximately 1.7 million episodes of acute agitation are treated in an emergency setting annually in the United States. Clinical manifestations follow a continuum of severity, ranging from a mere increase in ideation and behavioral activity to acute and violent episodes. The symptoms of acute agitation can escalate rapidly (minutes to hours) or slowly (weeks). While aggression and violence are not core features, acute agitation can quickly progress to the highest levels of intensity, with potentially dangerous behaviors, high risk of personal injuries (to people living with neurological conditions, medical personnel, and others), and property damage.


Once the symptoms have become severe, intervention in the emergency medical setting is often required. Currently there are no FDA-approved medications for acute treatment use outside medical settings.


We are developing NRL-1004, a proprietary nasal spray formulation of olanzapine and Intravail®, for the treatment of acute agitation in people with schizophrenia and bipolar disorder.* There are currently no outpatient immediate use 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 people living with schizophrenia and bipolar disorder in the United States. We completed Phase 1 clinical trials in 2023.

*NRL-1004 is a product candidate that has not been approved by the U.S. Food and Drug Administration for any indication.