FDA grants fast track designation to NRL-1 for epileptic seizures

Neurelis Inc. recently announced that it has received fast track designation from the FDA for NRL-1, or intranasal diazepam, for the management of epilepsy in pediatric, adolescent and adult patients who experience acute repetitive or cluster seizures.

“We are very excited to have received Fast Track Designation status with the FDA,” Craig C. Chambliss, president and CEO of Neurelis said in a press release. “We are looking forward to working with the FDA as we complete our clinical development work, assemble our [New Drug Application] submission, and prepare for the commercialization of NRL-1. We are focused on providing epilepsy patients and health care providers with an effective, well-tolerated, and user-friendly product for the treatment of acute repetitive or cluster seizures.”

NRL-1 is intended for selected, refractory patients with epilepsy who are already being treated with anti-epileptic drugs, but require intermittent use of diazepam to manage bouts of cluster seizures. The FDA previously granted orphan drug designation for NRL-1 in 2015.

“Presently, there remains an unmet need for epilepsy patients suffering from acute repetitive or cluster seizures,” Jacqueline French, MD, one of the lead investigators for NRL-1 and professor of neurology at New York University Langone's Comprehensive Epilepsy Center, said in the release. “The only approved option currently available requires rectal administration, which can be an issue – especially with adolescent and adult patients. We are studying NRL-1, whose unique formulation should allow us to deliver a therapeutic dose of diazepam via a well-tolerated nasal spray. This would allow for rapid treatment of these seizures where they occur — at home, work, school or elsewhere.”

The final stage of clinical development for NRL-1 is currently underway. Neurelis plans to submit its New Drug Application for NRL-1 by early 2018.