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

Inclusion Criteria:

- 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

Exclusion Criteria:

- Female subject who is pregnant, breastfeeding, or planning to become pregnant

- Presence or history of any abnormality or illness that may affect the absorption,
distribution, metabolism or elimination of diazepam

- Known allergy or hypersensitivity to diazepam, related drugs, or any of the
formulation components

- Positive screening test for ethanol or other drugs of abuse

- Unable to receive medications intranasally