LONDON (ShareCast) - (Sharecast News) - Futura Medical updated the market on regulatory and commercial progress for 'MED3000', its topical gel formulation for the treatment of erectile dysfunction, on Monday.
The AIM-traded firm said that, following the US Food and Drug Administration (FDA) agreeing that an application could be made as a medical device for ED treatment, a number of "productive and positive" pre-submission meetings were held with the FDA during 2020 and 2021.

Those meetings involved discussing existing phase 3 clinical data, the pathway to over-the-counter (OTC) status, and additional clinical and non-clinical requirements.

The company said the FDA required an additional six-month confirmatory clinical study, with MED3000 taking a 'least burdensome approach', as well as a short, non-clinical 'human factors' study to test the ability of subjects to self-diagnose their erectile dysfunction, correctly select the product based on label information, and test subject's ability to correctly use the product without the supervision of a doctor.

Futura said the FDA asked for a minimum of 15 subjects to complete the study.

The company said the human factors study was successfully completed with 32 subjects, demonstrating that individuals were able to correctly self-diagnose ED and to make correct self-selection decisions by considering their own health history and the instructions for use and warnings on the label.

"Overall, there was a very high degree of comprehension of the label and leaflet to increase confidence that the product will be used appropriately in an OTC setting," the company's board said in its statement.

"These results therefore support the regulatory submission for OTC designation and enable Futura to finalise the OTC product label for a US filing."

Looking at the US confirmatory clinical study, Futura said the study was designed to provide the FDA with the supplementary six-month efficacy data with a 'least burdensome' approach and "modest" cost.

In September, the first patient had entered pre-screening in the study, dubbed 'FM71'.

Just over 100 patients had now been successfully enrolled into the study, including a mix of mild, moderate and severe ED sufferers with patients recruited from eastern Europe, as well as African American patients from a "leading" US medical centre.

"The company aims to continue to recruit up to a further 10 patients, to allow for any patient drop-outs, before closing recruitment in the next few weeks," the board said.

Futura said timelines remained on track for the planned US regulatory submission by the end of the third quarter of 2022, and for targeting US OTC FDA approval of MED3000 in the first quarter of 2023.

Finally, Futura noted that 2021 saw several commercial licensing deals struck in large markets for ED, in regions including China and southeast Asia, Latin America and the Middle East.

The company said it was in advanced discussions for other commercial out-licensing agreements covering additional major regions and countries, with multiple interested parties.

Scale-up of manufacturing and production capacity to meet projected demand was also progressing "well" as the firm worked towards an initial launch of MED3000 in certain countries in 2022.

"We are continuing to make good progress with the regulatory process for MED3000 in the US," said chief executive officer James Barder.

"We are also executing upon our strategic plans to leverage commercialisation globally with a network of licensing and distribution partners with brand building strength, healthcare credibility and regional infrastructure and marketing expertise."

Barder described 2021 as a "year of transformational progress" for Futura.

"We look forward to further updates for shareholders during what we believe will be an exciting 2022 for Futura."

At 1021 GMT, shares in Futura Medical were up 4.11% at 32.9p.

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