FDA

Valtoco now approved for younger children

April 23, 2025

FDA approved Valtoco (diazepam nasal spray) for short-term treatment of seizure clusters (also known as “acute repetitive seizures”) that are different from a patient’s normal seizure pattern in patients with epilepsy ≥2 years of age.

Previously, the drug was approved in patients ≥6 years of age.

Efficacy

Approval of the expanded indication was based on data from a phase 1/2 pharmacokinetics (PK) study (NCT05076838) that evaluated diazepam nasal spray in pediatric epilepsy patients ages 2 to 5 years. Results showed that diazepam nasal spray was readily absorbed with similar exposure for patients aged 2 to 3 years and 4 to 5 years and also showed a consistent PK profile in 2 to 5 year olds with that of older children and adults aged 6 to 59 years.

The effectiveness of diazepam nasal spray in the 2 to 5 years age group was evaluated using the proportion of second doses (doses given within 24 hours of initial doses) used to treat seizure clusters as a proxy for effectiveness. Findings showed comparable rates of seizure clusters treated with second doses among pediatric patients aged 6 to 17 years in a long-term safety study of diazepam nasal spray, supporting the effectiveness of the age-based dosing regimen in patients aged 2 to 5.

Safety

Safety of Valtoco in patients aged 2 to 5 years was assessed through the 180-day open-label safety period of the phase I/II study. Overall, the safety profile was similar to that established for older children and adults.

Sources:

Neurelis announces FDA approval for immediate use seizure medication Valtoco (diazepam nasal spray) in ages 2 to 5. [News release]. 2025. https://www.neurelis.com/neurelis-announces-fda-approval-for-immediate-use-seizure-medication-valtoco-diazepam-nasal-spray-in-ages-2-to-5/

Neurelis Presents Studies on Seizure Clusters at the American Epilepsy Society Annual Meeting. [News release]. 2025. https://www.neurelis.com/neurelis-presents-studies-on-seizure-clusters-at-the-american-epilepsy-society-annual-meeting/

Valtoco (diazepam nasal spray) [package insert]. Neurelis. https://valtoco.com/VALTOCO_Prescribing_Information.pdf Revised April 2025. Accessed April 21, 2025.