RE: Positive results from WSD4000 Early Feasibility Study12 Jan 2026 07:32
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
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