Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)

To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel
(Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE)
meeting the definition of refractory epilepsy.

Inclusion Criteria:

- Diagnosis of refractory epilepsy

- Body weight 26 to 111 kilogram (kg) inclusive

- Other inclusion criteria apply

Exclusion Criteria:

- Male or female subject who is not surgically sterile or female subject who is less
than 2 years postmenopausal, and does not agree to use a highly effective birth
control method during the study and up to 3 months after the last dose of
investigational product

- 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

- Other exclusion criteria apply