- FDA expanded approval of diazepam nasal spray (Valtoco) for immediate treatment of seizure clusters in children aged 2 years and older.
- The technology utilized enables rapid intranasal delivery and carries a boxed warning due to associated risks.
- Diazepam nasal spray shows promising safety and pharmacokinetics in pediatric patients based on phase I/IIa study, presenting a meaningful advance for pediatric epilepsy treatment.
- Diazepam nasal spray is contraindicated in certain patients and classified as a Schedule IV controlled substance.
- Approximately 400,000 children in the United States are living with epilepsy.
Source: Neurelis press release
