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."