Results of WSD4000 Early Feasibility Study
WSD4000 early feasibility study shows statistically significant improvement in female sexual function across 12 women.
- Subjects in study 12
- Subjects completing study 11
- Average improvement in FSFI scale 6.35 units
- Minimal clinically important difference 4 units
- Sexual encounters recorded 56
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Futura Medical (AIM: FUM), the consumer healthcare Group behind Eroxon® that specialises in the development and global commercialisation of innovative and clinically proven sexual health products, is pleased to report positive results of the WSD4000 Early Feasibility Study ('EFS') which comprised of 12 women suffering from some degree of sexual dysfunction.
The positive trends and high response metrics demonstrate that the product has the potential to deliver a significant improvement in impaired sexual function in women. Given the lack of known regulatory-approved OTC treatment available for this condition in women, this represents a significant opportunity for WSD4000 globally.
EFS results
Whilst the size of the EFS study was relatively modest, the results are highly encouraging and give the Company confidence to proceed to the next steps of designing a Phase 3 clinical study which will be further informed by a small in-clinic sham / placebo controlled sensory study (results expected in mid 2026), and a 200 subject home user study (results expected in mid 2026).
| · | Using the internationally recognised Total Female Sexual Function Index ('FSFI') scale, a highly statistically significant improvement over baseline was achieved in overall sexual function |
| · | On average, an improvement in overall sexual function of 6.35 units over baseline (pre-treatment) in the FSFI scale was achieved which exceeded the minimal clinically important difference of 4 units defined by expert scientific consensus |
| · | Statistically significant improvements were achieved in five of the six FSFI domains: sexual arousal, lubrication, pain improvement, ability to orgasm and sexual satisfaction |
| · | Judged to be effective in both pre- and post-menopausal women |
| · | Using the Female Sexual Encounter Profile ('FSEP') metrics, meaningful improvements were achieved in all measures across the 56 sexual encounters recorded: |
o 64.2% of uses were described as experiencing moderate or high desire
o 83.9% of uses reported satisfaction with arousal
o 71.4% of uses reported enough lubrication for comfortable intercourse
o 69.6% of uses resulted in orgasm
o 78.6% of uses reported moderate or high arousal
o 91.1% reported conditions appropriate for a satisfactory sexual encounter
| · | Every use of the gel (56 in total) resulted in a genital sensation which occurred on average in less than five minutes in 9 out of 10 uses |
| · | The product was well tolerated. 58% subjects experienced a mild to moderate but transient "burning" sensation which in general led to higher efficacy levels indicating that subjects regarded this as a sensory signal that "the product was working". No subjects discontinued use of the product. |
About the EFS
The EFS of the WSD4000 prototype followed the Food and Drug Administration's ('FDA') guidance from a recent pre-submission meeting and was conducted to Good Clinical Practice ('GCP') standards and ethical principles for medical research. An EFS study was defined by FDA as a pre-requisite for the first in class (De Novo) medical device with OTC classification.
12 subjects were recruited into the study with 11 completing all elements: five pre-menopausal and six post-menopausal. After initial screening for suitability, subjects were formally diagnosed by using the FSFI instrument which is a fully validated self-completed questionnaire that has become the gold standard and most widely used measuring instrument in this scientific field1.
When entering the study, the subjects were measured pre-treatment at a baseline after four sexual encounters using the FSFI and measured post-treatment after four weeks and a minimum of four sexual encounters. In addition, subjects recorded their experience after each post-treatment sexual encounter using the FSEP instrument, another validated and widely used questionnaire.
About WSD4000
WSD4000 is a topical treatment designed for sexual dysfunction in women. Currently, no regulatory approved topical treatment for sexual dysfunction in women is available over the counter. WSD4000 has the potential to be an effective, breakthrough treatment for the common symptoms associated with sexual dysfunction, such as impaired arousal, lubrication and desire.
The market for WSD4000
According to published data, between 40% and 50% of women experience at least one symptom of sexual dysfunction2. Recently, the Company commissioned IPSOS to undertake market research in the US in 1,000 women, and this showed that around 60% have suffered from at least one symptom of sexual dysfunction in the last twelve months. In addition, only one in four women seek professional help and despite their efforts, many women continue to struggle with symptoms of sexual dysfunction with few women (13%) experiencing an improvement in symptoms over time and 37% getting worse over time3.
Ken James, Executive Director and Head of R&D, commented: "We are delighted with the results from the Early Feasibility Study which show clear and positive trends, demonstrating that the product can deliver a significant improvement in impaired sexual function in women. 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.
We look forward to updating the market over the coming months on the next steps for WSD4000, including results of the placebo and home user studies as a precursor to designing a Phase 3 clinical study, as well as preparation of product positioning, packaging and the launch strategy."
1Meston et al, Scoring and Interpretation of the FSFI. What can be learnt from 20 years of use? J Sex Med 2020 Jan 17(1):17-25
2Source: McCabe MP, Sharlip ID, Lewis R, Atalla E, Balon R etal. Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015. J Sex Med. 2016 Feb;13(2):144-52
3Ipsos research carried out on behalf of Futura Medical in the USA amongst 1,003 women, 2024
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