One of the Company's strategic priorities is to broaden its product range, leveraging its innovative and experienced R&D capability whilst being mindful of costs and focusing on return on investment for shareholders.
Eroxon® Intense will provide a range extension for the current Eroxon® product and acts as an additional treatment option for men who have erectile dysfunction, helping those men that may prefer a stronger and faster sensorial action from Eroxon®.
Marketing experience with Eroxon® has shown that whilst many men are satisfied with the current sensorial effect of the product, some men would prefer a stronger sensation. Eroxon® Intense will help those men, thereby broadening the existing Eroxon® range.
Enhanced formulation in proof of concept study
In a single-blind randomised crossover design study, 16 male subjects blind tested three enhanced formulations compared with Eroxon®. 67% of the men experienced greater sensorial sensitivity on the preferred formulation compared to Eroxon®. A preferred enhanced formulation with a favourable side effect profile was selected for further testing.
Pivotal claim support study
The further study which concluded in March 2025 is a pivotal claim support study in 45 healthy male subjects aged 18-70 years in the UK. The study was a blinded, comparator controlled crossover design with a randomised treatment sequence and compared the chosen formula from the smaller sensory study conducted in 2024, referred to as Eroxon® Intense with Eroxon®. The results strongly support the previous study findings. The results showed statistically significantly stronger sensation for Eroxon® Intense, observed within 15 seconds of application up to 10 minutes from application vs Eroxon®. There was a low incidence of adverse events for both treatment groups.
HUT Study Results
The study, completed in March 2026, compared the new Intense formulation with current Eroxon® over 4 weeks in 223 subjects (112 tested Eroxon® and 111 tested Eroxon® Intense). Subjects were male, 18-59 years of age and 94% assessed as suffering from mild to moderate erectile dysfunction. In this selected demographic, both Eroxon® and Eroxon® Intense were shown to have high efficacy rates. Subjects stated that they were satisfied with the hardness of their erection in 70% and 71% of their sexual encounters using Eroxon® or Eroxon® Intense, respectively. Subjects also recorded that their erections lasted long enough to have sexual intercourse in 84% and 85% of encounters, respectively.
Using the clinically validated and most widely used measure of erection functionality (the IIEF-EF scale5), subjects in both groups 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. The study also showed that when either Eroxon® or Eroxon® Intense was applied onto the study participant by their partner it increased effectiveness and showed significantly higher erection maintenance. The study confirmed the sensorial enhancement of Eroxon® Intense over Eroxon® with statistically significant greater intensity during the first two minutes after application. Both products were well tolerated in men and their female partners.
Both formulations received favourable 4-star or 5-star ratings in 49% and 53% of subjects for Eroxon® and the Eroxon® Intense formulation respectively. Over 50% of study participants said they would be somewhat or very likely to purchase either product.
In summary, the HUT study confirmed that a more targeted approach of marketing to consumers under 60 years of age with mild to moderate ED will likely lead to higher efficacy and satisfaction rates and thus higher in-market repeat purchase rates. Encouraging users to use the product with their partners as part of foreplay will likely also improve the overall product experience. The Eroxon® Intense formulation will appeal to those consumers seeking a more rapid or stronger sensorial effect, especially in younger age groups.
Regulatory clearance in the US and EU expected by Q3 2026
Futura will be utilising the prior regulatory approvals already in place in the EU and USA. Data necessary to support regulatory filings for Eroxon® Intense in Europe and the USA has been generated and a "Special" 510K submission has been filed with the US FDA. In the EU Eroxon® Intense is within scope of the existing device registration for Eroxon® and only requires Futura to update the technical documentation we maintain for the EU and UK registrations. Market launch clearance is expected in June 2026 in the EU/UK and regulatory clearance in the US is expected in Q3 2026. Eroxon® Intense will be covered under Futura's existing intellectual property.
Focus for 2026
Eroxon® Intense offers the opportunity for commercial partners to expand the reach and appeal of the Eroxon® portfolio to offer additional benefits to consumers. We are working with our manufacturing partners to establish the supply chain for Eroxon® Intense and expect Eroxon® Intense to be available in its first markets from early 2027. As part of the forthcoming launch of Eroxon® Intense, the Group is undertaking a review of the brand architecture, optimal positioning and claims for both products and other elements of the brand and product range to ensure it is aligned with consumer needs and expectations.