Neurelis has announced that its intranasal diazepam candidate, NRL-1, has received Fast Track designation by the Food and Drug Administration (FDA).
The designation was granted specifically 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 acute repetitive or cluster seizures.
“We are looking forward to working with the FDA as we complete our clinical development work, assemble our NDA submission, and prepare for the commercialization of NRL-1,” said Craig C. Chambliss, president and CEO of Neurelis.
NRL-1 is delivered via a nasal spray and has previously been granted Orphan Drug status. The NRL-1 clinical development program is in its final stages with a new drug application planned for early 2018. In clinical trials, NRL-1 has demonstrated high bioavailability, low variability from dose to dose, and was well-tolerated.
“The only approved option [for acute repetitive seizures] currently available requires rectal administration, which can be an issue – especially with adolescent and adult patients,” said Jacqueline French, MD, and professor at NYU Lagone’s Comprehensive Epilepsy Center, where researchers are currently studying NRL-1.
Speaking about the potential advent of a nasal spray, Dr. French said, “This would allow for rapid treatment of these seizures where they occur, at home, work, school or elsewhere.”
For more information visit Neurelis.com.