Futura Medical PLC (AIM:FUM, OTC:FAMDF) has hailed the regulatory and marketing progress of its erectile dysfunction gel, MED3000, over the past year, which has gained marketing authorisation in three Middle Eastern countries and is being reviewed by the US regulator.
The company filed an application for marketing authorisation with the US Food & Drug Administration (FDA) in October, presenting MED3000 as an effective clinically proven treatment with a 10-minute onset of action and a favourable benefit versus risk profile ideally suited for OTC (Over The Counter) classification.
This followed the FDA last year requesting an additional Phase 3 clinical study, results from which announced this August demonstrated all primary and secondary endpoints had been met with a highly favourable safety and tolerability profile with no serious adverse events recorded.
Futura said the FDA has now confirmed that the dossier is “under formal review and has indicated that the dossier has successfully passed the initial technical screening”.
“Based on the FDA's published target review period guidelines, granting of marketing authorisation remains on track to be achieved by the end of Q1 2023, in line with previously announced timelines,” the company said in a statement.
The AIM-listed company said the search for a US commercial partner has begun and its corporate advisors are engaged in “a number” of ongoing discussions.
The product, which is marketed under the Eroxon brand, obtained its UKCA mark as a Class 2A medical device in April, to supplement its European CE mark, and after that the company signed multiple commercial agreements throughout Europe, the UK, the Gulf, Switzerland and South Korea.
With initial launches planned in the first half of 2023, Futura said it is expanding its network of licensing and distribution partners.
A first production order of Eroxon has been received to enable initial launches through European and UK distribution partner, Cooper Consumer Health, which is said to remain on track.
First production for initial launches in the Middle East are planned for 2023, with an agreement through distribution partner Labatec Pharma.