Futura Medical PLC (AIM:FUM, OTC:FAMDF, FRA:GYX), the consumer healthcare company behind the erectile dysfunction gel Eroxon, said its experimental treatment for female sexual problems outperformed a placebo in studies.
The company reported results on Tuesday from a home user test and a placebo-controlled study of WSD4000, a topical product aimed at women with impaired sexual response and function.
WSD4000 was statistically superior to placebo across each of the key measures of arousal, genital sensation and lubrication at every time interval tested, from one minute to 15 minutes.
That study assessed the product against a placebo control in an in-clinic cross-over trial involving 33 pre- and post-menopausal women.
The separate home user test evaluated WSD4000 in 228 pre-, peri- or post-menopausal women over four weeks.
In that test, 78% of women reported a general improvement in all or most aspects of sex, while 81% noticed an improvement in their overall sexual function.
The share of participants reporting an improved sexual experience rose from 77% after a single use to 84% after four uses.
After four uses, 83% of women experienced improved lubrication, 82% reported improved genital sensation and 75% reported improved arousal.
The product was generally well tolerated, though 18% of women experienced a transient unpleasant sensory effect, an issue the company said could be managed through clearer consumer explanation at launch.
Futura said the results strengthened its confidence in the commercial potential of WSD4000 and would allow it to design a cost-effective pivotal clinical study.
The company expects to begin that clinical study by the end of 2026, subject to additional funding.
Ken James, executive director and head of research and development, said the data gave the company confidence that WSD4000 could become the first clinically proven, regulatory-approved multi-symptom treatment for sexual problems in women.
Futura anticipates a market launch from early 2028, subject to completion of the pivotal trial and regulatory approval.
The company pointed to independent US research, conducted with 1,000 subjects, showing that 60% of women had suffered at least one symptom of impaired sexual response and function in the previous twelve months.
Only one in four of those affected sought professional help, the research found, while symptoms worsened over time for 37% of women.
There is currently no regulatory-approved topical treatment available over the counter anywhere in the world for impaired sexual response and function in women.
