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VALTOCO™ (diazepam nasal spray)

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 believed 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, 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 must have 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 action plan that includes an on-hand rescue treatment. 
 

Presently, a majority of patients experiencing a seizure that requires medical intervention to stop it rely on emergency medical services. This frequently results in treatment delays, increased costs, and a considerable disruption in day-to-day life. Other patients try to avoid a trip to the emergency room by using an on-hand rescue treatment. Unfortunately, the currently available on-hand rescue treatment options are limited and sub-optimal for a majority of patients, resulting in a clear unmet need for another on-hand rescue treatment option.

About VALTOCO™ (diazepam nasal spray)

  • VALTOCO nasal spray 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).*

 

  • In November 2015, Neurelis received Orphan Drug Designation from the FDA for VALTOCO nasal spray 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, VALTOCO nasal spray 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.

  • In August 2018, Neurelis submitted a New Drug Application (NDA) for VALTOCO nasal spray to the FDA.

*VALTOCO nasal spray 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.