Futura Medical PLC (AIM:FUM, OTC:FAMDF) has announced positive developments for two prospective sexual health products, aiming to broaden its lineup and target both men’s and women’s health needs.
The innovations — WSD4000 and Eroxon Intense — have completed initial proof-of-concept studies, and are potential follow-ons to Eroxon, the first over-the-counter erectile dysfunction drug to be approved in the US and is being commercially rolled out worldwide.
The former, a topical gel for women’s sexual dysfunction, could become the first over-the-counter treatment for common issues like low desire and arousal, a space with limited options currently.
In a preliminary clinical study, 40% of women, including 63% of post-menopausal women, reported feelings of arousal after trying the preferred WSD4000 formulation.
Following these results, a larger “real-world” study is now underway with 60 participants, and initial results are expected in early 2025.
Futura also held its first "pre-submission" meeting with the US Food and Drug Administration (FDA) on WSD4000, setting the groundwork for a potential clinical trial path as an over-the-counter treatment.
For male consumers, Futura is developing Eroxon Intense, an enhanced version of its popular erectile dysfunction gel.
While the current product has satisfied many users, market research showed demand for a more intense effect.
In a test with 16 men, 67% noted a stronger sensation with the preferred enhanced formulation.
Consumer trials for Eroxon Intense are expected to proceed in the first half of 2025, and Futura aims for regulatory approval in both the United States and Europe by year’s end.
Futura anticipates covering development costs within its existing budget, and ongoing partner discussions signal potential commercial support and market expansion for both products.
CEO James Barder said: "I am delighted to announce that our highly experienced R&D team has wasted no time in focusing on developing exciting new innovations within the OTC sexual health area.
"Having successfully developed, commercialised and signed world-class partnerships for our first product, Eroxon, we are excited to announce the next phase of our NPD roadmap."