Neurelis says that it has received guidance from the FDA regarding clinical trial requirements for the company’s NRL-1 intranasal diazepam for the treatment of acute repetitive seizures in epilepsy patients and is now initiating the pivotal trial program for the product.
Neurelis President and CEO Craig C. Chambliss commented, “We were pleased to obtain guidance from the FDA confirming the continued advancement of the clinical development of NRL-1 consistent with their expectation of data required to file the NDA. This clinical development path will support the use of NRL-1 in pediatric, adolescent, and adult epilepsy patients who suffer from acute repetitive seizures. We believe that the ease of use of this product in a nasal spray – combined with the bioavailability, safety, and tolerability – can benefit these patients by helping to successfully manage acute repetitive seizures in an outpatient setting.”
In 2014, Neurelis regained the rights to NRL-1 from Biotie, which had paid $1 million in 2013 for an option to purchase Neurelis. In December 2015, the company announced that the FDA had granted orphan drug status to NRL-1.
Neurelis is also developing intranasal lorezepam for the treatment of anxiety disorders.
Read the Neurelis press release.
