Futura’s MED3000 gains CE mark in Europe

Futura’s MED3000 gains CE mark in Europe
MED3000 gaining a CE mark in the European Union is a “transformational milestone” for Futura Medical, says chief executive officer James Barder

3 May 2021 - Deborah Wilkes

Futura Medical’s MED3000 topical gel for erectile dysfunction has now been certified as a Class IIb medical device in the European Union. The company told OTCToolbox it was "in discussions with a number of parties" about marketing and distribution rights.

The company said MED3000 was the “first clinically-proven, pan-European topical OTC treatment for adult men with erectile dysfunction”.

Futura Medical added that “manufacturing scale up and commercial discussions continue to progress well”.

The company has not disclosed likely launch dates.

The news comes soon after the company said the European Union Notified Body had successfully completed its review of the MED3000 technical dossier with a recommendation to certificate the product as a Class IIb medical device (click here to read the News story). 

Transformational milestone

Chief executive officer James Barder described the certification as a “transformational milestone” for the UK-based product development company.

In 2020, Futura Medical reported a net loss of GBP2.41 million (USD3.32 million), compared with a net loss of GBP8.92 million the previous year (click here to read the News story).

The company, which reported no revenue in 2020, said it continued to “accelerate progress towards achieving a significant, continuous revenue stream within a few years”.

Futura Medical added that it was focusing its “financial and human resources on late-stage clinical development of its fast-acting topical treatment for erectile dysfunction”.

Paves the way in other markets

The company pointed out that the recent certification paved the way for rapid approval of MED3000 in many countries and regions around the world – including Africa, the Far East, Latin America and the Middle East – which allow a fast-track review based on recognition of the European Union’s CE mark. Depending on the country, added Futura, approvals were likely to take up to 12 months from the time of submission.

The CE mark would also be recognised in Great Britain until 30 June 2023, said Futura, noting that it planned to secure the new post-Brexit UKCA mark. “This will be a streamlined process,” the company added, “since it is understood the UK application can bridge to the European Union approval.”

Futura Medical said it continued to progress marketing approval for MED3000 in the US for use as a non-prescription product.

Collaboration in China and South-East Asia

In addition, the company recently announced a collaboration with private-equity firm Co-High Investment Management to commercialise MED3000 in China and South-East Asia (click here to read the News story).

According to Futura, MED3000 had the potential to be a “highly-differentiated product by addressing significant unmet needs, across all patient severities in the USD5.6 billion global erectile-dysfunction market”.

MED3000 had a “unique evaporative mode of action”, said Futura Medical, adding this was believed to “stimulate nerve endings in the glans penis to cause an erection”.

The company added that the product helped men get an erection within 10 minutes, which was “substantially faster than oral phosphodiesterase-5 inhibitors”.

Futura said MED3000 could become the first globally available, clinically-proven, OTC treatment for erectile dysfunction.

“There has been little innovation in erectile dysfunction treatments for over 10 years,” commented the company, “and many patients continue to suffer dissatisfaction with existing treatments.”

Professor David Ralph – consultant urologist at the UK’s University College London and past president of the European Society of Sexual Medicine – said the efficacy of MED3000 “approaches the efficacy of current first line therapy but with significantly lower adverse events”.

“With topical application, it will be of particular appeal to patients who want a fast onset of action,” remarked Ralph, adding the “lack of drug interactions with prescription products will enable the product to be used with other medications such as nitrates and other cardiovascular drugs".

Ralph said MED3000 could also potentially be used in conjunction with other erectile-dysfunction products to improve overall efficacy to patients.

Futura Medical said one in five men globally experienced erectile dysfunction.

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