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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 patient, 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.


  • NRL-4 is being developed as a noninvasive, as-needed therapy for use outside the medical setting to address symptoms of acute agitation associated with schizophrenia and bipolar mania 1 in adults.*


  • The unique formulation of NRL-4 incorporates Intravail® from the Neurelis technology platform to address some of the challenges commonly encountered with intranasal administration.


  • NRL-4 is in the initial stage of development and presents a worldwide commercial opportunity for Neurelis.

*NRL-4 is a product candidate that has not been approved by the U.S. Food and Drug Administration for any indication.