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Epilepsy patients have limited on-hand rescue treatment options

There are more than 3.4 million people with epilepsy in the United States. The number of people diagnosed with epilepsy continues to rise, with approximately 200,000 new patients diagnosed each year.
 
A seizure emergency is defined as a seizure lasting longer than 5 minutes, or 2 or more seizures happening without improvement in between. The longer a seizure lasts, the less likely it will stop on its own without medication. Seizure emergencies can lead to numerous complications, including neurological damage, or even death in some cases. It is important that seizure emergencies are identified and treated early to improve outcomes. Due to the fact that a majority of seizures occur outside the medical setting, patients may benefit from an on-hand rescue treatment in order to control a seizure in a timely manner.
 
People with epilepsy have limited options to stop a seizure once it has started. While most seizures resolve relatively quickly on their own, some do not and may require medical intervention. It is often impossible to predict when a seizure will require treatment to stop it. For this reason, people with epilepsy should be prepared with a seizure response plan that may include an on-hand rescue treatment. Unfortunately, the currently available on-hand rescue treatment options are limited.

About NRL-1 (Intranasal Diazepam) WITH INTRAVAIL®

  • NRL-1 is an investigational on-hand rescue treatment being developed for children, adolescents and adults with epilepsy who experience bouts of increased seizure activity while on a stable regimen of daily antiepileptic medication(s).*

  • This proprietary intranasal formulation of diazepam is designed to be administered outside the medical setting by a family member or caregiver.

  • This unique formulation leverages Intravail from the Neurelis technology platform. Intravail helps overcome common challenges encountered with intranasal administration of benzodiazepines.

  • In 2015, Neurelis received Orphan Drug Designation from the FDA for NRL-1 in the treatment of acute repetitive seizures.

  • In 2016, NRL-1 received Fast Track Designation from the FDA.

  • In 2018, Neurelis submitted a New Drug Application (NDA) for NRL-1 to the FDA.

*NRL-1 is an investigational drug product being evaluated for use in children and adults with epilepsy on stable regimens of antiepileptic drugs (AEDs) to control bouts of increased seizure activity and has not been approved by FDA for any indication.