The FDA has expanded the approval of diazepam nasal spray (Valtoco) for the immediate treatment of seizure clusters in children as young as 2 years old. The formulation is clinically superior to rectal diazepam gel and utilizes transmucosal absorption enhancement technology for rapid intranasal delivery. This advancement fills a significant unmet need for epilepsy treatment in children and is supported by data from a phase I/IIa study, showing promising safety and pharmacokinetics in pediatric patients. Valutoco carries a boxed warning and is classified as a Schedule IV controlled substance.

Source: Neurelis press release