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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. The annual economic burden of epilepsy worldwide is estimated to be >$15B. It is estimated that 30% to 40% of epilepsy patients are uncontrolled on their current therapy and are at risk for experiencing a seizure emergency, which can cause neurological damage and increased risk for death.
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, neurological damage, or even death in some cases. It is important that seizure emergencies are identified and treated early to improve outcomes. 

Patients with epilepsy have limited on-hand rescue treatment options. Presently, a majority of patients experiencing a seizure emergency still rely on emergency medical services. This frequently results in considerable disruption and treatment delays. Meanwhile, others try to avoid a trip to the emergency room by using an on-hand rescue therapy. Today, there is only one FDA-approved product for treatment of seizure emergencies (increased bouts of seizure activity) outside the medical setting. However, due to its route of administration, diazepam rectal gel is generally reserved for young pediatric patients. As a result, other patients utilize oral medications that are not indicated for this use and should not be used in an actively seizing patient.  The currently available treatments of seizure emergencies are sub-optimal for a majority of patients, resulting in a clear unmet need for another on-hand rescue treatment option. 

About NRL-1

  • NRL-1 is an investigational on-hand rescue treatment to control increased bouts of seizure activity (seizure emergencies) that is being developed for use in children, adolescents, and adults.*


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


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


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


  • This unique formulation leverages the Neurelis technology platform in an effort to address some of the common challenges frequently encountered with intranasal delivery of benzodiazepines.

  • Neurelis is conducting a Phase 3 clinical trial prior to submitting a New Drug Application (NDA) to the FDA requesting marketing approval.

*NRL-1 is an investigational drug product being evaluated for children and adults who require intermittent use of diazepam to control increased bouts of seizure activity and has not been approved by FDA for any indication.