What is Eroxon ® Intense and when will it be available?
Eroxon® Intense is an additional treatment option for erectile dysfunction that is aimed at helping the cohort of men that may prefer a stronger and faster sensorial action from Eroxon®.
We are expecting regulatory approval in the EU and USA in Q3 2026.
What is WSD4000 and when will it be available?
WSD4000 is a project name for our development female sexual health portfolio, starting with the creation of a range of topical gels under our unique platform technology, specifically designed to treat impaired sexual response or function (sexual dysfunction) in women, providing improvements in sexual desire, arousal, lubrication, pain during intercourse, orgasm and overall sexual satisfaction. The range of gels, supported by a single phase 3 clinical programme, will comprise different consumer segments such as pre- and post-menopausal women.
As part of the regulatory process, Futura met with the Food and Drug Administration (“FDA”) who indicated that an early feasibility study was a pre-requisite as this would be the first in class (De Novo) medical device with OTC classification for this indication. A small study was set up with 11 subjects completing the study (five pre-menopausal and six post-menopausal women) who had some degree of sexual dysfunction. The results of this study were highly encouraging.
As part of a structured development programme, the next steps include:
- A home‑use testing (“HUT”) and a placebo (sham) controlled in-clinic study to ensure sufficient separation between sham and active in the pivotal clinical and confirm study numbers currently underway with results expected in June and following the HUT results, subject to them being positive, progressing to a full phase 3 clinical study (subject to new funding).
Building the plans for a targeted market launch in Q1 2028 under the new commercial model and gaining early expressions of interest from potential commercial partners.