Extended indication Chlamydial infections and Gonorrhoea (Prevention)
Therapeutic value Possibly no place in the treatment regimen
Registration phase Clinical trials

Product

Active substance Citric acid / lactic acid / potassium bitartrate
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Bacterial infections
Extended indication Chlamydial infections and Gonorrhoea (Prevention)
Proprietary name Phexxi
Manufacturer Evofem Biosciences
Mechanism of action Other
Route of administration Vaginal
Therapeutical formulation Gel
Budgetting framework Extramural (GVS)
Additional comments Fabrikant: Evofem Biosciences, Inc. Al geregistreerd in de Verenigde Staten als Contraception.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen
Dosage per administration 5mg
References NCT03107377
Additional comments 5 g dose applied up to 1 hour prior to coitus

Expected patient volume per year

Additional comments 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
References drugs.com
Additional comments The cost for Phexxi vaginal gel (1%-1.8%-0.4%) is around $289 for a supply of 60 grams, depending on the pharmacy you visit.

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

Indication extension No
References Adis Insight
Additional comments Geen andere indicaties op dit moment onderzocht in fase 2 of 3.

Other information

There is currently no futher information available.