FDA clears Neurelis IND to commence NRL-1 clinical trials for acute breakthrough seizures

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."