MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)
Peakmidazolam injection, 10 mg
NDAINTRAMUSCULARSOLUTIONPriority Review
Approved
Aug 2022
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) (midazolam injection, 10 mg) is mechanism of action the exact mechanism of action for midazolam in the treatment of status epilepticus is not fully understood, but is thought to involve potentiation of gabaergic neurotransmission resulting from binding at the benzodiazepine site of the gabaa receptor. Approved for status epilepticus in adults. First approved in 2022.
Drug data last refreshed 5d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Midazolam hydrochloride autoinjector is an intramuscular benzodiazepine injection delivering 10 mg for emergency treatment of status epilepticus in adults. It works by potentiating GABAergic neurotransmission at the GABAA receptor, enabling rapid seizure control via self-administered or caregiver-administered autoinjector delivery. Absorption is rapid (median Tmax 0.5 hours) with straightforward hepatic metabolism via CYP3A4.
Peak
Product recently approved (2022) and in peak commercial phase; team likely focused on market penetration and provider education in emergency medicine and neurology channels.
Mechanism of Action
Mechanism of Action The exact mechanism of action for midazolam in the treatment of status epilepticus is not fully understood, but is thought to involve potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABAA receptor. Pharmacodynamics The effects…
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.