NDARECTALGEL3 Generics Approved
Approved
Jul 1997
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
7
Data completeness
5/8 — Partial
DIASTAT ACUDIAL (diazepam) by Bausch + Lomb. Approved for benzodiazepine [epc]. First approved in 1997.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIASTAT ACUDIAL is a rectal gel formulation of diazepam, a benzodiazepine approved in 1997 for acute seizure management and alcohol withdrawal syndrome. It works by enhancing GABA-mediated inhibition at GABA-A receptors in the central nervous system, suppressing excessive neuronal depolarization that generates and spreads seizures. The rectal delivery route provides rapid, non-invasive access for acute seizure intervention.
$0.023BPart D
LOE ApproachingDeclining
Minimal commercial activity and approaching loss of exclusivity indicate a niche, cost-managed product with limited team expansion opportunities.
Mechanism of Action
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
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
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
A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
Started Feb 2011
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.