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Diazepam nasaal

VALTOCO

Extended indication Epilepsy patients who experience frequent breakthrough seizures or acute repetitive seizures.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Diazepam nasaal
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Epilepsy
Extended indication Epilepsy patients who experience frequent breakthrough seizures or acute repetitive seizures.
Proprietary name VALTOCO
Manufacturer Neurelis
Route of administration Nasal
Therapeutical formulation Nose spray
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Particularity New therapeutical formulation
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Midazolam neusspray
Therapeutic value No estimate possible yet
References NCT02721069
Additional remarks NRL-1 will be administered as needed to treat bouts of those seizures over a 12-month period of time. Doses will be defined as 5mg, 10mg, 15mg or 20mg based on the subject's body weight.

Expected patient volume per year

Patient volume

< 78,000

Market share is generally not included unless otherwise stated.
References GIP
Additional remarks In 2022 waren er 77.922 gebruikers van midazolam

Expected cost per patient per year

References drugs.com
Additional remarks De prijs in de Verenigde Staten is ongeveer $300 tot $400 per spray.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.