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 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.
Neurelis, Inc., is a neuroscience company providing an approach to target unmet medical needs. Neurelis is focused on the development and commercialization of product candidates for epilepsy and the broader central nervous system (CNS) market. On January 10, 2020, the FDA approved Neurelis’ VALTOCO (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual’s usual seizure pattern in adult and children 6 years of age and older.
This was reported by Neurelis, Inc. on November 23, 2020.
Contact information: Mark Leonard, Media Contact, Neurelis, Inc., 3430 Carmel Mountain Road, Suite 300, San Diego, California 92121; 858-251-2100; Email: firstname.lastname@example.org; Website: https://www.neurelis.com