WSD4000 - For the treatment of sexual dysfunction in women

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 lack of arousal, lubrication and desire.

Between 40% and 50% of women experience at least one symptom of sexual dysfunction¹, with frequency of symptoms increasing after menopause, yet women remain chronically underserved. Existing prescription treatments offer a poor benefit-risk profile and fail to meet the needs of many women.

In an initial single-blind randomised crossover study set up by Futura, 16 female subjects blind tested three gel formulations in a clinic. The study tested one application of each gel with 40% of women and 63% of post-menopausal women reporting feelings of arousal after using the preferred gel formulation in a clinic setting. Following this initial proof of concept study, the next stage of development is to mimic a "real world" situation in a home user study with 60 female subjects and multiple product uses. This study is underway with the aim of being able to provide initial validation for the product with results expected during Q1 2025.

As part of the development of the regulatory strategy Futura has engaged with the US FDA to validate the product concept and take steps to define the full development programme. A first pre-submission meeting with FDA was conducted with a successful outcome. The official minutes of the FDA meeting confirmed the potential OTC² status of WSD4000 and a further meeting with the FDA is planned to discuss the pivotal clinical study design following the "least burdensome" principles.

A new patent for WSD4000 was filed in February 2024, with the potential for further filings based on the outcomes of the studies. The innovation behind WSD4000 falls outside of existing commercial partner agreements for Eroxon^®.

The commercialisation strategy for WSD4000 will be determined by the Board following the completion of the home user study, and evaluation of market research commissioned by the Company that it expects will complete by early 2025. Discussions with potential commercial partners are ongoing.