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

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

MED3000 Clinical Programme

• 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 5mgfor the treatment of ED over a 24-week period (1,2)

Open Image in Modal

In a study (4)

• MED3000, a topical gel, was tested on 250 patients in a 12-week, multi-center, randomized, double-blind, parallel-group study (FM57) that included men with a clinical diagnosis of ED for >3 months
• patients or their female partners administered MED3000
• in a second multi-center, randomized, open-label, parallel-group study (FM71), MED3000 was compared with 5 mg oral tadalafil over 24 weeks in 96 men with ED
• study results:
  • approximately 60% of patients using MED3000 achieved clinically meaningful improvements in IIEF-EF domain scores in each of the two studies
  • 60.1% and 44.9% achieved erections in <10 minutes in FM57 and FM71, respectively
  • overall, less than 2% of the men who usedMED3000 and 4% of those who took tadalafil reported adverse effects
    • events included headaches in 3% of the combined MED3000 group and 19.1% of the tadalafil group
    • about1% of men who used MED3000 reported penile burning sensation compared with none in the group taking tadalafil
  • study authors concluded:
    • "..data from these pivotal studies resulted in the approval of MED3000 in the United States. MED3000 met the minimal clinically important difference (MCID) for improving erectile function with a favorable safety profile. This novel topical agent may be useful for men with ED who are not candidates for a phosphodiesterase type 5 (PDE5) inhibitor, who cannot tolerate adverse events associated with these agents, or who have suboptimal responses to them.."

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
• Hellstrom WJG et al. PD52-07 - Efficacy and safety of MED3000, a novel topical therapy for the treatment of erectile dysfunction. Journal of Urology 2024; 211 (5S): e1074