Neurelis, Inc. said today that it won fast track designation from the FDA for its intranasal diazepam spray. The nasal formulation of diazepam, which is being developed for pediatric and adult epilepsy patients who experience repititive or cluster seizures, is in the final stage of clinical development, according to Neurelis. The company expects to submit a new drug application to the federal watchdog by early 2018.
“We are very excited to have received fast track designation status with the FDA,” president & CEO Craig Chambliss said in prepared remarks. “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. 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.”
“Presently, there remains an unmet need for epilepsy patients suffering from acute repetitive or cluster seizures,” lead investigator Dr. Jacqueline French added. “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 San Diego-based company’s spray received orphan drug designation from the FDA in December 2015.