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Psychomotor agitation (PMA) is a common and costly phenomenon in several psychiatric disorders, including schizophrenia and bipolar disorder. A staggering 1.7 million episodes are reported annually in the United States. Clinical manifestations follow a continuum of severity, ranging from a mere increase in ideation and behavioral activity to very acute and violent episodes. The symptoms of PMA can escalate rapidly (minutes to hours) or slowly (weeks). While aggression and violence are not core features, PMA 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. Strategies to reduce the number and severity of PMA episodes are being implemented to reduce costs to the healthcare system and alleviate patient suffering.


Early identification and prompt intervention are critical to reduce the likelihood for symptomatic escalation and the need for acute medical intervention. Early self or care partner recognition of symptoms and/or triggers may provide a window of opportunity for episodic prevention in certain patients. Currently, there are no FDA-approved medications for acute use outside medical settings. A treatment option for early intervention outside of the emergency room is vital.


  • NRL-4 is being developed as a noninvasive rescue therapy to address the escalation of PMA symptoms outside the medical setting.*


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


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

*NRL-4 is a product candidate that has not been approved by FDA for any indication.