Extended indication Bacterial Vaginosis
Therapeutic value Possible equal value
Total cost 126,000.00
Registration phase Clinical trials

Product

Active substance Clindamycin
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication Bacterial Vaginosis
Manufacturer Daré Bioscience
Mechanism of action Other
Route of administration Vaginal
Therapeutical formulation Gel
Budgetting framework Extramural (GVS)
Additional comments fabrikant: Daré Bioscience, Inc.

Registration

ATMP No
Submission date 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Clindamycine crème (ook oraal)
Therapeutic value Possible equal value
Substantiation Er is al een crème op de markt om lokaal te behandelen, huidig product is een gel. Beiden zijn geschikt voor intra vaginale toediening (applicator bijgeleverd). Er wordt een vergelijkbare effectiviteit verwacht.
Frequency of administration 1 times a day
Dosage per administration 5 g clindamycin phosphate vaginal gel, 2% (100 mg clindamycin)
References NCT04370548

Expected patient volume per year

Patient volume

< 3,600

Market share is generally not included unless otherwise stated.

References GIP databank
Additional comments In 2020 waren er 3.562 gebruikers van ATC-subgroep G01AA10 : Clindamycine.

Expected cost per patient per year

Cost < 35.00
References GIP databank
Additional comments In 2020 was de prijs per patiënt per jaar van ATC-subgroep G01AA10 : Clindamycine €34,91.

Potential total cost per year

Total cost

126,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References Adis Insight

Other information

There is currently no futher information available.