eroxon (MED3000) (topical GTN (glyceryl trinitrate)) for erectile dysfunction (ED)

Last edited 06/2023 and last reviewed 07/2023

Eroxon (MED3000) (topical GTN (glyceryl trinitrate)) for erectile dysfunction (ED)

• MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of male erectile dysfunction ("ED")
  
  
• MED3000 is a treatment applied directly to the head (glans) of the penis and massaged for 15 seconds.
  • ED sufferers or their partners can apply the gel directly to the man's penis as part of foreplay (1)
  • is fast-acting helping men get an erection within 10 minutes, and easy to use helping to restore spontaneity and intimacy in the relationship whilst offering an excellent safety profile
  • utilises DermaSys technolody (1)
    • Dermasysis a drug delivery technology platform that provides rapid and targeted local delivery of active pharmaceutical ingredients (API) at therapeutic levels to the required site of action
    • application of gel with API leads to a combination of solvents including volatile solvents
      • then volatile solvents evaporate, leaving the remaining solvent supersaturated with API
      • in turn, derives API through the tissue and then API penetrated the skin rapidly offering rapid penetration or sustained release
    • GTN promotes vasodilation through local absorption into penile vasculature, minimising systemic uptake
      • GTN is absorbed into the penile blood system and is converted to nitric oxide, which has the effect of relaxing muscles surrounding the corpus cavernosa and dilating the penile arteries
      • allows the corpus cavernosa to engorge with blood and following sexual stimulation, an erection occurs

Evidence of benefit

• FM71 is a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically-applied MED3000 gel compared to tadalafil 5mg for the treatment of ED over a 24-week period (1,2)
  • investigated the efficacy and safety of MED3000 gel in 96 male subjects clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from the United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both.
  • subjects enrolled into the FM71 study for the initial four weeks had to attempt intercourse on at least four occasions in order to establish the severity of their ED known as the 'baseline', after which MED3000 was used as per trial protocol for 24- weeks
  • MED3000 achieved a clinically important improvement in subjects erectile function at all time points and was clinically effective in mild, moderate and severe ED sufferers - subjects experienced a 5.73 unit change in IIEF-EF score versus baseline at 24 weeks exceeding the 4-unit difference agreed with the FDA and defined as the Minimal Clinical Important Difference ("MCID") (3) (Primary Endpoint) (1)
    • 61% of MED3000 users exceeded the MCID at 24 weeks compared with 87% tadalafil 5mg users (2)
  • MED3000 demonstrated a rapid speed of onset, where subjects noticed an erection at 10-minutes, (Secondary Endpoint) which was demonstrably faster than tadalafil 5mg used in the study
  • Comparison of Adverse events MED3000 vs Tadalafil (5mg) (>2 incidences) (2)
  • 

Note that "there is a sparcity of publically accessible medical literature and evidence regarding the efficacy and safety of MED3000/"Eroxon" but this agent has been approved both in the United States and the United Kingdom for "over the counter" use. I could not find any specific publication regarding MED3000 on pubmed and the only description of the FM57 findings that I could use as a reference was the conference poster cited below" Dr Jim McMorran, Editor in Chief GPnotebook (June 24th 2023)

Reference:

• Futura Medical Developments Ltd. https://www.futuramedical.com/what-we-do/med3000/med3000-overview/
• Ralph D et al. MED3000, a clinically proven, fast-acting topical product for Erectile Dysfunction with the prospect of being the first globally available OTC treatment for ED.European Society for Sexual Medicine (poster presentation).
• Rosen RC et al “Minimal clinically important differences in the erectile function domain in the International Index of Erectile Function Scale Eur Urol 2011;60(5):1010-6