Diagnosis of drug-resistant epilepsy

Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)

Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit

A caregiver must consent to participate together with the subject for purposes of observation and data collection

The caregiver must be present when the investigational product is administered

Screening body weight between 26 to 111 kg, inclusive

An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.