Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DBF, DBSF
Diazepam Buccal Film · 3 trials · 1 indication
AUC calculated from time 0 (dosing) to 4 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
AUC calculated from time 0 (dosing) to 2 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Tmax calculated from time 0 (dosing) to 2 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Tmax calculated from dosing (Time 0) to 4 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Maximum observed plasma concentration measured from Time 0 to 2 hours post-dose in Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Maximum observed plasma concentration from Time 0 to 4 hours post-dose in Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Observed time to reach maximum drug concentration (Tmax)
Observed Peak Drug Concentration (Cmax)
Area under the Plasma Concentration -time curve from time zero until the last measured time (AUC0-t)
Area Under Plasma Concentration-Time Curve From Time Zero to the last non-zero concentration
Area under concentration time curve, from time 0 extrapolated to infinity
Maximum observed plasma concentration
| Arm | Type | Description |
|---|---|---|
| Interictal Period | EXPERIMENTAL | Each subject received a single dose of DBF based on the subject's age and weight. |
| Ictal/Peri-ictal Period | EXPERIMENTAL | Each subject received a single dose of DBF based on the subject's age and weight. |
| Diazepam Buccal Film, Then Diastat Rectal Gel | EXPERIMENTAL | Participants received a single dose of Diazepam Buccal Film following a moderate-fat meal and then received a single dose of Diastat Rectal Gel following a moderate-fat meal with a 28-day washout between doses. |
| Diastat Rectal Gel, Then Diazepam Buccal Film | EXPERIMENTAL | Participants received a single dose of Diastat Rectal Gel following a moderate-fat meal and then received a single dose of Diazepam Buccal Film following a moderate-fat meal with a 28-day washout between doses. |
| Diazepam Buccal Film following a High-Fat Meal | EXPERIMENTAL | Participants who volunteered to participate in the second period received a second dose of Diazepam Buccal Film at the same dose and exactly the same manner as the earlier dose with the exception that the dose was administered following ingestion of a high-fat meal. |
| Name | Type | Description |
|---|---|---|
| Diazepam Buccal Film | DRUG | Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses. |
| Diazepam Buccal Film 12.5 mg | DRUG | All subjects received a single dose of DBF 12.5 mg during the interictal state and during the ictal/peri-ictal state with at least 14 days washout between the 2 treatment periods |
| Diastat® Rectal Gel (Valeant Pharmaceuticals USA) | DRUG | Diastat Rectal Gel administered rectally according to product label administration and dosing instructions (10 mg to 20 mg according to body weight) following ingestion of a moderate-fat meal. |
Inclusion Criteria: Potential subjects meeting all of the following criteria may be included in the study: 1. Subjects have a clinical diagnosis of epilepsy (GTC seizures or focal seizures with impaired awareness) and were scheduled for admission to an Epilepsy Monitoring Unit (EMU), General Clini...
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| Xenon Pharmaceuticals Inc. | XENE | 4 | PHASE3 | Azetukalner |
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| Rapport Therapeutics, Inc. | RAPP | 3 | PHASE3 | RAP-219 |
| Supernus Pharmaceuticals, Inc. | SUPN | 4 | PHASE2 | SPN-817, BIS-001ER |
| Biohaven Ltd. | BHVN | 3 | PHASE2 | BHV-7000 |
| Harmony Biosciences Holdings, Inc. | HRMY | 1 | PHASE3 | Clemizole |
| Jazz Pharmaceuticals Public Limited Company | JAZZ | 3 | PHASE1 | CBD-OS, Epidiolex |
| Bright Minds Biosciences Inc. | DRUG | 1 | PHASE2 | BMB-101 |
| uniQure N.V. | QURE | 1 | PHASE1 | AMT-260 |
Diazepam Buccal Film is an investigational small molecule therapy being developed for epilepsy. It is designed to deliver diazepam through the buccal mucosa, the lining of the mouth, as an alternative to rectal administration. It is being developed by Aquestive Therapeutics, Inc. (ticker: AQST) and is currently in Phase 2 clinical development.
Diazepam Buccal Film is being studied for use in epilepsy, specifically for the treatment of seizure clusters. It is intended to provide a non-rectal route of diazepam administration for patients experiencing acute repetitive seizures. The drug is investigational and has not been approved by the FDA for any indication.
Diazepam Buccal Film targets GABA-A receptor subunits, specifically GABRA1, GABRB2, GABRG2, GABRB3, GABRA4, and GABRG3. It acts as a positive allosteric modulator at these receptors, enhancing the inhibitory effects of GABA in the central nervous system to help suppress seizure activity.
Diazepam Buccal Film is being developed by Aquestive Therapeutics, Inc., which trades under the ticker symbol AQST. The company is responsible for the clinical development of this investigational epilepsy therapy.
Diazepam Buccal Film is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Three clinical trials have been completed, and there are currently no active trials listed for this asset.
Diazepam Buccal Film has been evaluated in three completed clinical trials: NCT03953820, a Phase 1 crossover study comparing Diazepam Buccal Film to Diastat Rectal Gel in 31 adults; NCT03222349, a Phase 2 pharmacokinetics and safety study in 24 pediatric subjects; and NCT03179891, a Phase 2 study in 35 adults with epilepsy.