Posted by Michael Wonder on 05 Jan 2017
Neurelis intra-nasal diazepam treatment for epilepsy granted fast track designation by FDA
4 January 2017 - Neurelis today announced that the US FDA has designated NRL-1 (intranasal diazepam) as a fast track development program for the management of selected, refractory patients with epilepsy, on a stable regimen of anti-epileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizures – also referred to as acute repetitive or cluster seizures.
NRL-1 is being developed for paediatric, adolescent, and adult epilepsy patients who experience acute repetitive or cluster seizures. The program is in the final stage of clinical development and the NDA application is planned for submission by early 2018.
