Diazepam nasaal Medicine 04 June 2024 Extended indication Epilepsy patients who experience frequent breakthrough seizures or acute repetitive seizures. Therapeutic value No estimate possible yet Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name VALTOCO Manufacturer Neurelis Portfolio holder Mechanism of action Unknown Route of administration Nasal Therapeutical formulation Nose spray Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New therapeutical formulation ATMP No Submission date 2024 Expected Registration 2025 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Midazolam neusspray Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 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. Maximum patient volume for sluice References GIP Additional remarks In 2022 waren er 77.922 gebruikers van midazolam Expected cost per patient per year Cost References drugs.com Additional remarks De prijs in de Verenigde Staten is ongeveer $300-$400 per spray. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks