Futura Medical PLC (AIM:FUM, OTC:FAMDF) said it has now completed all the work required to make its submission for regulatory sign-off from the US Food and Drug Administration (FDA) for MED3000, its fast-acting erectile dysfunction (ED) gel.
It expects to receive marketing approval towards the end of the first quarter of next year.
Chief executive James Barder called the application a "pivotal milestone", not just in the development of MED3000, but for the drug developer and its investors.
Named Eroxon, the gel works more quickly than pills such as Viagra and Cialis, which can take 30-60 minutes to get going, while it has none of their side effects.
US sign-off as a de novo medical device would follow its April 2021 success in securing European CE Mark.
Eroxon is expected to be the first ED drug to be sold over the counter in the States.