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.

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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).*
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In November 2015, Neurelis received Orphan Drug Designation from the FDA for VALTOCO nasal spray in the treatment of acute repetitive seizures.
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This proprietary intranasal formulation of diazepam is designed to be administered outside the medical setting by a family member or caregiver.
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In December 2016, VALTOCO nasal spray received Fast Track Designation from the FDA.
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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.
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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.