Neurelis Completes Pre-IND Meeting with FDA for Acute Agitation Treatment

Neurelis has concluded a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding NRL-4. The FDA provided direction for the clinical development pathway for the investigational treatment. NRL-4 is being investigated as a noninvasive, easy-to-administer rescue therapy to address the escalation of acute agitation symptoms outside the medical setting. Acute agitation is associated with several psychiatric disorders, including schizophrenia and bipolar mania 1 in adults.

NRL-4 is a proprietary formulation incorporating the science of Intravail®, which provides consistent and reliable absorption of medication via a proven, commercially available, single-use nasal sprayer. Intravail transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. Neurelis is able to leverage the formulation, developmental, and regulatory success of its FDA-approved product to optimize the pathway to regulatory submission and approval of NRL-4.

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 very 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 rescue use outside medical settings.

"Early identification and prompt intervention are critical to reduce the likelihood for symptomatic escalation and the need for acute medical intervention," said Enrique Carrazana, M.D., Chief Medical Officer of Neurelis. "Early recognition of symptoms and/or triggers, whether by the patient or caregiver, may provide a window of opportunity for episodic prevention in many patients. A treatment option for early intervention is a vital and significant unmet need among this patient population."