The FDA has accepted an Investigational New Drug application (IND) submitted by San Diego, CA pharmaceutical company Neurelis. The company is cleared to begin clinical trials for the development of its NRL-1 intranasal diazepam for the treatment of acute breakthrough seizures. According to the company, it 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.”
Neurelis Chairman David F. Hale commented, “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. 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 would be the first intranasal medication for acute repetitive seizures. The only currently approved dosage forms are rectal and intravenous, and Neurelis anticipates that intranasal diazepam would eliminate many emergency department visits by providing a convenient alternative for home use.
Read the Neurelis press release.
