The FDA has granted orphan drug designation to Neurelis’s lead product, NRL-1 intranasal diazepam for the treatment of acute repetitive seizures in epilepsy patients, the company said. Biotie paid $1 million for an option to buy Neurelis and rights to the product in 2013 but returned the rights in July 2014.
Neurelis President and CEO Craig C. Chambliss commented, “We are pleased to have received Orphan Drug Designation from the FDA based on the potential clinical benefit of NRL-1 to patients who experience acute repetitive seizures. Pediatric, adolescent, adult patients and their caregivers desire an effective, reliable, and well-tolerated treatment alternative to either rectal diazepam or an emergency room visit. We are committed to bringing NRL-1 to the epilepsy community for this very purpose. This designation is an important milestone to achieve as we continue the clinical development program for NRL-1.”
Read the Neurelis press release.
