Neurelis Completes Pre-IND Meeting With FDA To Establish Clinical Development Program For NRL-4 In The Treatment Of Acute Agitation Associated With Schizophrenia & Bipolar 1 Mania In Adults

Neurelis, Inc., announced that it 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 . . .