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Futura Medical ‘very pleased’ by Eroxon testing results

ALN

Futura Medical PLC on Monday announced ‘positive’ home user test results for its Eroxon and prototype Eroxon Intense products.

The Guildford, Surrey-based developer of sexual health products said the HUT results showed an overall improvement on its original phase 3 study for the original Eroxon product, a topical gel treatment for erectile dysfunction.

Additionally, Futura said it was confident that the new Intense formula produced a ‘statistically significant greater sensorial effect’ than the original formula.

Futura said the study, of 223 UK-based male users aged 18 to 59 years, showed that both Eroxon and Intense had high efficacy rates, and that according to the IIEF-EF scale, users of both products showed a highly significant and clinically important improvement in their erectile function.

‘The improvement versus baseline (pre-treatment) was at least as good as reported in the phase 3 clinical study FM71, which was used to obtain regulatory approval in the US,’ Futura added.

It also said the products were well-tolerated both by the subjects and their sexual partners.

Futura, as a result of the study results, expects ‘a more targeted approach of marketing to consumers under 60...with mild to moderate ED’ to ‘likely lead to higher efficacy and satisfaction rates and thus higher in-market repeat purchase rates.’ It expects Intense to particularly appeal to younger consumers.

‘Detailed work is now underway to assess and update optimal brand positioning. Meanwhile, data necessary to support regulatory filings for Eroxon Intense in Europe and USA has been generated and a ’Special’ 510K submission has been filed with the US FDA,’ Futura said. ‘Regulatory authorisation in the US and Europe is expected in H1 2026.’

Shares in Futura closed up 2.6% at 1.18 pence on Monday in London.

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