
Home » FDA clears IND for treatment of acute seizures
FDA clears IND for treatment of acute seizures
February 10, 2012
The FDA has cleared Neurelis’ Investigational New Drug application (IND) to commence clinical trials advancing the development of NRL-1, a diazepam nasal spray for the treatment of acute breakthrough seizures, according to Neurelis.
Following initial pre-IND discussions with FDA in late 2011, Neurelis filed the IND based on 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 the FDA agreed to in the pre-IND discussions that 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," said 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,” he said. “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."
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