According to Neurelis, the company has submitted an NDA for its diazepam nasal spray, now called Valtoco, for the treatment of cluster seizures in epilepsy patients aged six years and older. The nasal spray, previously known as NRL-1, was granted orphan drug designation in December 2015 and Fast Track designation in December 2016.
Neurelis President and CEO Craig Chambliss said, “Cluster or acute repetitive seizures are both dangerous and highly disruptive in the lives of epilepsy patients. Valtoco was developed to provide an effective combination of reliability, safety, and tolerability in a simple, ready-to-use nasal spray.”
Chambliss added, “Neurelis is passionately focused on providing this important product for epilepsy patients who may benefit from having an on-hand seizure rescue treatment that can be administered outside a medical setting. It has been more than twenty years since a new therapy has been approved for the treatment of cluster or acute seizures. This lack of novel and innovative therapies is a significant unmet need in the epilepsy community that needs to be addressed.”
Read the Neurelis press release.
