Citric acid / lactic acid / potassium bitartrate Medicine 07 December 2021 Extended indication Chlamydial infections and Gonorrhoea (Prevention) Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Clinical trials Product Active substance Citric acid / lactic acid / potassium bitartrate Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Chlamydial infections and Gonorrhoea (Prevention) Current proprietary name Already available biosimilars / generics Proprietary name Phexxi Manufacturer Evofem Biosciences Portfolio holder Mechanism of action Other Route of administration Vaginal Therapeutical formulation Gel Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Al geregistreerd in de Verenigde Staten als voorbehoedsmiddel. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory 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 Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 5g References NCT03107377 Additional remarks 5g vaginaal aanbrengen ongeveer een uur voor de geslachtsgemeenschap 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 verwachting is dat het gebruik erg laag of er niet zal zijn. De voorkeur van arts en patiënt gaat waarschijnlijk naar een tabletvorm uit. Expected cost per patient per year Cost € < 250.00 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 drugs.com Additional remarks De kosten voor Phexxi vaginale gel (1%-1.8%-0.4%) is rond de $289 voor een hoeveelheid van 60 gram in de VS. 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 indicaties op dit moment onderzocht in fase 2 of 3. Other information Additional remarks