Futura gearing up for US approval, launches of erection gel

Drug delivery technology developer Futura Medical updated the market on the regulatory progress and recent commercial activities for its ‘MED3000’ topical gel treatment for erectile dysfunction (ED).

The AIM-traded firm said the first marketing authorisation for MED3000 had now been granted in three Middle East countries, including the United Arab Emirates.

It said more approvals were expected into 2023 alongside initial launches, where regulatory approval had been received, under the ‘Eroxon’ brand.

In the United States, meanwhile, Futura noted that in 2021, the Food and Drug Administration (FDA) requested an additional phase-three clinical study for MED3000, designed to provide 24-week efficacy and safety data.

The study protocol was agreed with the FDA before starting it in September last year.

Results, announced in August, demonstrated that all primary and secondary endpoints had been met, with a “highly favourable” safety and tolerability profile and no serious adverse events.

Based on those results, Futura filed an application for marketing authorisation as a ‘De Novo’ medical device in October, presenting the case that MED3000 is an “effective, clinically-proven treatment” for ED with a 10-minute onset of action, and a favourable benefit-risk profile ideally suited for over-the-counter classification.

The company said the FDA had now confirmed that the dossier was under formal review, and had indicated that it had successfully passed initial technical screening.

Based on the FDA's published target review period guidelines, granting of marketing authorisation remained on track to be achieved by the end of the first quarter of 2023, in line with its previously-announced timelines.

In Europe, in April Futura obtained the UKCA mark for MED3000 as a class-2A medical device, required due to post-Brexit arrangements, supplementing the EU CE-mark obtained in 2021.1

“We are delighted with the significant progress we have achieved during 2022 and are looking forward to 2023 which we believe will be a very exciting and pivotal year for the company with initial launches of Eroxon - the brand name for MED3000,” said chief executive officer James Barder.

“We remain on track to be granted US marketing authorisation for MED3000 by the end of the first quarter of 2023 as a clinically proven, fast-acting, topical treatment with a highly favourable side effect profile for ED patients, without the need for a doctor's prescription.

“As we move towards initial launches and strategic scale up of commercialisation of Eroxon in the first half of 2023, we hope to be able to transform the lives of ED patients around the world with our breakthrough over-the-counter product.”

At 1224 GMT, shares in Futura Medical were up 2.55% at 49.2p.

Reporting by Josh White for Sharecast.com.