Futura Medical said its novel, topical gel formulation for the treatment of erectile dysfunction (ED), MED3000, is now available in Europe.
Under the brand name Eroxon, the ED gel is available for purchase across the continent online, the pharmaceutical company said in a statement.
Eroxon will also be available in retail pharmacies in Belgium from 1 April, “supported by an advertising and promotional campaign.”
Further country launches remain on track during the coming months, Futura added, supported by advertising and promotional campaigns.
Today’s announcement builds on last year’s exclusive licensing agreement signed with Cooper Consumer Health, which gained the rights to commercialise MED3000 throughout the EEA, United Kingdom, and Switzerland.
Analysts at Liberum said that commercial progress is in line with its expectations and it is "encouraging" to see the first retail pharmacy launch in Belgium.
AIM-listed Futura also said it expects its De Novo request to the US Food and Drug Administration (FDA) to be granted in the second quarter of this year.
Last October, Futura filed an application for the US marketing authorisation for its MED3000 medical device via the De Novo regulatory pathway.
The US Food and Drug Administration has requested some more information, which Futura expects to provide by the end of this month to “enable FDA to complete their review.”
A De Novo pathway classifies novel medical devices for which general controls alone provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device, the FCA website stated.
Libreum said that it remains confident in receiving FDA approval for MED3000, and if anything its confidence has been strengthened.
“We are in constructive active dialogue with the FDA and believe we are making solid progress in our efforts to be granted OTC marketing authorisation for MED3000 by the FDA which is now anticipated in the second quarter of 2023,” said chief executive James Barder.
Futura believes that MED3000 has the potential to become the first over-the-counter treatment for erectile dysfunction.