Sofpironium bromide Medicine 08 June 2021 Extended indication Hyperhidrosis Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Clinical trials Product Active substance Sofpironium bromide Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Unknown Extended indication Hyperhidrosis Current proprietary name Already available biosimilars / generics Proprietary name ECCLOCK Manufacturer Brickell Biotech Portfolio holder Mechanism of action Receptor antagonist Route of administration Local Therapeutical formulation Gel Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Aluminiumzouten (1e lijn), botox (2e lijn) Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Er is een marginaal effect geconstateerd plus een heel aantal bijwerkingen (4 x zoveel milde bijwerkingen). De verwachting is dat de voorkeur aan botox gegeven zal worden. Duration of treatment Frequency of administration 1 times a day Dosage per administration 15% References NCT03948646, NCT03836287, NCT03627468 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks De geschatte prevalentie van hyperhidrosis axillaris is in Nederland 1%-3%, voor de ernstige vorm is dit 1%. Dus maximaal 170.000 patiënten. Er wordt met de huidige kennis geen gebruik van dit geneesmiddel verwacht. Expected cost per patient per year Cost € 964.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Additional remarks De lijstprijs voor ECCLOCK® is in Japan ¥243.70 per gram. Dat is ¥4,874.00 (€37,09) voor een flesje van 20 gram oftewel een voorraad voor 2 weken. 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 No Indication extensions References Adis Insight Additional remarks Geen andere lopende fase 3 studies Other information Additional remarks