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 provides a potential range extension of 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 sensation 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 has now been selected for further consumer testing during H1 2025, with regulatory approval in the EU and USA expected by the end of 2025.
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.
Regulatory and commercial outlook
The Company's commercial partners have shown strong interest for new variants beyond the original Eroxon® product to expand the product range as they seek to build out the sexual health category within their own businesses and meet retailers expectations for product line extensions. Therefore, an additional treatment option for erectile dysfunction that is aimed at helping the cohort of men that may prefer a stronger sensation from Eroxon® is commercially attractive to support users' needs as well as commercial partners' strategic ambitions. Eroxon® Intense will be covered under Futura's existing intellectual property.
Futura expects the regulatory pathway to be straightforward for Eroxon® Intense as Futura will utilise the prior regulatory approvals already in place in the EU and USA. In the USA, the Group will submit a 510k submission later induring H2 2025 with marketing authorisation from the US FDA expected around two months later subject to further questions from the FDA. We are therefore expecting regulatory approval in the EU and USA by the end of 2025, giving our commercial partners a product extension to Eroxon®.