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nasal diazepam
Nasal diazepam is a benzodiazepine that enhances inhibitory GABAergic neurotransmission in the central nervous system when administered intranasally.
Nasal diazepam is a benzodiazepine that enhances inhibitory GABAergic neurotransmission in the central nervous system when administered intranasally. Used for Acute seizure management and seizure cluster treatment, Acute anxiety and agitation.
At a glance
| Generic name | nasal diazepam |
|---|---|
| Also known as | Nasal diazepam (Valtoco) |
| Sponsor | University of Cincinnati |
| Drug class | Benzodiazepine |
| Target | GABA-A receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology; Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Diazepam binds to benzodiazepine receptors on GABA-A receptors, potentiating the effect of the inhibitory neurotransmitter GABA. This results in sedation, anxiolysis, muscle relaxation, and anticonvulsant effects. The intranasal formulation provides rapid onset of action, bypassing first-pass hepatic metabolism and enabling faster CNS penetration compared to oral administration.
Approved indications
- Acute seizure management and seizure cluster treatment
- Acute anxiety and agitation
Common side effects
- Sedation
- Dizziness
- Drowsiness
- Ataxia
- Respiratory depression
Key clinical trials
- Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care (PHASE4)
- A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants (PHASE1)
- Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy (PHASE1, PHASE2)
- Effects of Diazepam on RNS Detections (PHASE4)
- Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis (PHASE2)
- A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers (PHASE1)
- Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®) (PHASE2)
- An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray. (PHASE2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |