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

Multi-center, Open-label, Study of Safety and Tolerability of Chronic Intermittent Usage of Diazepam Nasal Spray in Adolescents and Adult Patients With Cluster Seizures, Including Assessment of Olfaction and Reported Changes in Taste.

This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).

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