Neurelis has announced that its NRL-1 intranasal diazepam has received Fast Track designation from the FDA for the treatment of acute repetitive or cluster seizures in epilepsy patients. The company plans to submit an NDA for the product by early 2018.
The FDA granted NRL-1 orphan drug designation in 2015, and Neurelis announced the initiation of pivotal trials in early 2016.
Neurelis President and CEO Craig C. Chambliss commented, “We are very excited to have received Fast Track Designation status with the FDA. 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.”
Lead investigator Jacqueline French of NYU Langone Comprehensive Epilepsy Center said, “Presently, there remains an unmet need for epilepsy patients suffering from acute repetitive or cluster seizures. 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.”
Read the Neurelis press release.
