Neurelis Announces FDA Allowance of IND Application for NRL-1, a Novel Intranasal Diazepam Formulation Acceptance of Investigational New Drug Application is another significant milestone in the effort to address the significant need for a therapy for acute repetitive seizures outside of the hospital setting.
SAN DIEGO, Feb. 6, 2012 /PRNewswire/ -- Neurelis, Inc. today announced that the United States Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence clinical trials advancing the development of NRL-1 for the treatment of acute breakthrough seizures. Following initial pre-IND discussions with FDA in late 2011, Neurelis filed the IND based upon the encouraging human pharmacokinetic results seen when comparing absolute bioavailability of NRL-1 relative to intravenous diazepam administration in healthy subjects. In the IND submission, Neurelis formalized plans for the remaining clinical and non-clinical requirements that FDA agreed to in the pre-IND discussions which will support the submission for marketing approval.
"We are encouraged with our interactions with the FDA and the formalization of our development plan for NRL-1. The acceptance of the IND is a significant step in advancing the development of this important therapy," stated David F. Hale, Chairman of Neurelis. "We believe that NRL-1 has demonstrated a pharmacokinetic profile and bioavailability which has not been seen with previous attempts at the intranasal delivery of benzodiazepines. With the successful development of NRL-1 and approval from the FDA and other regulatory agencies, we look forward to making this product available to those patients who have epilepsy and suffer from acute repetitive seizures."
NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam delivered via a commercially available nasal sprayer. It is being developed for the management of patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity. 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% to 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.
Presently, the only product approved for the treatment of acute repetitive seizures outside of the hospital setting, is a rectally administered formulation of diazepam called Diastat®. Because of its rectal mode of administration, Diastat® has been primarily relegated to use in younger pediatric patients (usually less than 10 years of age). The majority of patients with acute repetitive seizures; however, are currently seen in emergency rooms and treated with intravenous benzodiazepines. Most of these patients are admitted to the hospital. This represents a significant component of the estimated $15 billion annual economic burden on the system to treat epilepsy in the U.S. Intranasal diazepam would provide a more convenient alternative to either rectal administration of Diastat® or the need to visit the emergency room for intravenous administration of drugs.
Neurelis, Inc. is a 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.
Contact: David F. Hale
SOURCE Neurelis, Inc.