5 Key Takeaways

• 1

  The FDA has expanded the approval of diazepam nasal spray (Valtoco) for treating seizure clusters in children as young as 2 years old.

• 2

  Valtoco utilizes INTRAVAIL® technology for rapid intranasal delivery and was previously granted orphan drug exclusivity.

• 3

  The expanded indication is supported by a phase I/IIa study on safety and pharmacokinetics in pediatric patients.

• 4

  Common adverse events include somnolence, headache, and nasal discomfort, with a boxed warning for risks associated with opioid use.

• 5

  Valtoco is contraindicated in patients with hypersensitivity to diazepam and is not approved for neonates or infants.