NDANASALSPRAY
Approved
Jan 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
5/8 — Partial
VALTOCO (diazepam) by Neurelis is mechanism of action although the precise mechanism by which diazepam exerts its antiseizure effects is unknown, animal and in vitro studies suggest that diazepam acts to suppress seizures through an interaction with γ-aminobutyric acid (gaba) receptors of the a-type (gaba a ). First approved in 2020.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALTOCO is a nasal spray formulation of diazepam, a benzodiazepine indicated for acute seizure management. It works by enhancing GABA receptor activity in the central nervous system, increasing chloride ion flow into neurons and raising the threshold for seizure generation. The nasal route provides rapid onset of action for emergency seizure control.
$17MPart D
Peak15.7 years to LOEThe product is at peak lifecycle stage with modest Medicare spending, indicating a stable but niche market with opportunities for medical affairs and regional sales roles.
Mechanism of Action
Mechanism of Action Although the precise mechanism by which diazepam exerts its antiseizure effects is unknown, animal and in vitro studies suggest that diazepam acts to suppress seizures through an interaction with γ-aminobutyric acid (GABA) receptors of the A-type (GABA A ). GABA, the major…
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants
Started Jun 2025
55 enrolled
Healthy Participants
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
Started Nov 2021
35 enrolled
Epilepsy
Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
Started Jan 2018
149 enrolled
Epilepsy
Treatment Of Alcohol Withdrawal Syndrome: Dexmedetomidine Vs Diazepam In A Hospital O'horán
Started Nov 2017
2 enrolled
Alcohol Withdrawal Delirium
Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy
Started Aug 2017
24 enrolled
Epilepsy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.