VITAROS cream (alprostadil), medicine used to treat erectile dysfunction
Reason for request
No clinical benefit demonstrated in the treatment of erectile dysfunction due to organic causes over the available alternatives
VITAROS cream has Marketing Authorisation in the treatment of erectile dysfunction in adults.
It only concerns erectile dysfunctions due to organic causes.
This is a new alternative to the currently available alprostadil-based proprietary medicinal products for the symptomatic treatment of erectile dysfunction due to organic causes.
The studies provided, versus placebo only, did not enable to demonstrate a benefit compared with the other already-available proprietary medicinal products.
Improvement in actual benefit