Neurelis Initiates Pivotal Clinical Program for NRL-1 in the Treatment of Acute Repetitive Seizures
Following the receipt of Orphan Drug Designation for their lead product, NRL-1 (intranasal diazepam), Neurelis, Inc. ("Neurelis") today announced the receipt of guidance from the FDA for the final clinical trial requirements necessary for approval of NRL-1. NRL-1 is being developed for pediatric, adolescent, and adult epilepsy patients who experience Acute Repetitive Seizures. Neurelis has initiated the pivotal clinical trials program to support a New Drug Application (NDA) in the US.
"We were pleased to obtain guidance from the FDA confirming the continued advancement of the clinical development of NRL-1 consistent with their expectation of data required to file the NDA," stated Craig C. Chambliss, President and Chief Executive Officer of Neurelis. "This clinical development path will support the use of NRL-1 in pediatric, adolescent, and adult epilepsy patients who suffer from Acute Repetitive Seizures. We believe that the ease of use of this product in a nasal spray - combined with the bioavailability, safety, and tolerability - can benefit these patients by helping to successfully manage Acute Repetitive Seizures in an outpatient setting."
NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam, delivered via an already marketed nasal sprayer, being developed for the management of pediatric and adult patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity. NRL-1 has been granted Orphan Drug Designation by the FDA. In clinical trials, NRL-1 has demonstrated high bioavailability, low variability from dose to dose, and was well-tolerated. There are over 2.7 million people with epilepsy in the United States with approximately 200,000 new patients diagnosed each year. It is estimated that between 30% and 40% of these patients are uncontrolled on oral therapy and are at-risk for acute breakthrough seizures. Studies have shown that prolonged or repetitive seizures can cause neurological damage and dramatically increase the risk of changes in neuropsychological function or even death.
Neurelis, Inc. is a privately-held San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system (CNS) market. Neurelis leverages expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates to address significant unmet medical needs.