Shares in Futura Medical PLC (AIM:FUM, OTC:FAMDF) rose 11% to 1.45p on Monday after the company unveiled positive early-stage trial results for a new gel aimed at treating sexual dysfunction in women, a potential first in the over-the-counter market.
The AIM-listed group, best known for its erectile dysfunction product Eroxon, said its WSD4000 gel had shown “highly statistically significant” improvements in sexual function during a small feasibility study.
The results, which exceeded clinically recognised benchmarks, have given the company confidence to proceed with further trials.
Twelve women took part in the study, which followed US Food and Drug Administration guidelines. Eleven completed the trial, including both pre- and post-menopausal participants. Sexual function was assessed before and after using the gel via two established clinical questionnaires.
The first, the Female Sexual Function Index, showed an average improvement of 6.35 points, comfortably above the 4-point threshold considered the minimum for a clinically meaningful benefit.
The women reported improvements in arousal, lubrication, orgasm, satisfaction and pain reduction.
The second survey, based on 56 recorded sexual encounters, showed that the gel took effect rapidly and consistently. In over 90% of uses, participants reported genital sensation within five minutes, and nearly 70% of encounters resulted in orgasm.
Most users also reported satisfactory levels of arousal and lubrication.
There were no dropouts due to side effects. Some participants experienced a temporary burning sensation, which the company said was generally perceived as a sign the product was working.
Futura plans to follow up the early data with two further studies in 2026: a placebo-controlled trial and a 200-subject home-use study.
If those results are positive, the company intends to pursue a larger phase III trial, the final step before seeking regulatory approval.
While treatments exist for male sexual dysfunction, there are currently no approved over-the-counter topical products for women. Futura believes WSD4000 could fill that unmet need.
The market potential appears substantial. The company cited research showing that 40–50% of women experience symptoms such as low desire or impaired arousal, yet only a minority seek professional help.
A survey of 1,000 US women commissioned by Futura found that 60% had experienced at least one symptom in the past year.
Ken James, head of research and development, said: “We are delighted with the results… which show clear and positive trends.
"With our specialism in developing and bringing to market topically delivered gel formulations for improved sexual health, we believe we can successfully build on these results and provide a treatment for a condition that affects a significant number of women worldwide.”