Diazepam Nasal Spray Receives FDA Approval for Seizure Clusters in Individuals 2 Years and Older

Neurelis' nasal spray gains FDA approval for seizure treatment

The US Food and Drug Administration (FDA) has granted approval for Neurelis’ diazepam nasal spray, Valtoco.

FDA expands diazepam nasal spray for seizure clusters to ages 2–5

Diazepam nasal spray (Valtoco) is approved for short-term treatment of seizure clusters, now in patients aged 2 years and older.

FDA Approves Diazepam Nasal Spray for Treatment of Seizure Clusters in Pediatric Patients

The drug is approved for the short-term treatment of acute repetitive seizures, also known as seizure clusters, which differ from a patient’s normal seizure pattern.

Diazepam Nasal Spray Receives FDA Approval for Seizure Clusters in Individuals 2 Years and Older

The safety profile of diazepam nasal spray among pediatric patients was consistent with older patients, supporting its use in this age group.

FDA Expands Diazepam Nasal Spray Indication to Treat Ages 2 to 5

The intranasal treatment, originally marketed in 2020, will now be available for patients with acute repetitive seizures as young as 2 years old.

Aflibercept: Applications for dosing duration and additional indications pending decision with FDA and EMA

A decision on a longer dosing duration for the high-dose formulation is expected by April 20, 2025.