Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Diazepam Buccal Soluble Film 5, 7.5, 10, 12.5, 15 or with individual dose determined according to age and weight category · 1 trial · 1 indication
A TEAE was defined as any adverse event with onset date on the day of or after administration of study drug including relationship and severity.
A.Oral irritation related AEs including but not limited to: buccal mucosal swelling, mouth ulceration, injuries to oral cavity (such as tongue or mucosal laceration, broken tooth, bleeding), erythema, stomatitis, gingivitis, xerostomia, staining, dysphagia, dysgeusia, burning, stinging, tingling. B. Abuse related AEs including euphoria, euphoric mood, feeling of relaxation, anger, dissociative effects, hallucinations, psychosis, changes in mood, impaired cognition, attention, psychomotor effects, inappropriate affect, overdose, and misuse. C. Other: Respiratory disorders, nervous system disorders
| Arm | Type | Description |
|---|---|---|
| Subjects with Epilepsy | EXPERIMENTAL | Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening. |
| Name | Type | Description |
|---|---|---|
| Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category | DRUG | The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff. |
Inclusion Criteria: 1. Female or male subject between the ages of 2 and 65 years of age, inclusive 2. Written informed consent to participate in the study 3. Subject has an established diagnosis of epilepsy either partial or generalized epilepsy with motor seizures with clear alteration of awarenes...