A novel, FDA approved, over-the-counter topical therapy has shown promise for treating erectile dysfunction.
MED3000 (Eroxon), approved last June, was evaluated in two clinical studies of men diagnosed with erectile dysfunction (ED). The first study, a 12-week, multi-center, randomized, double-blind trial, tested the efficacy of MED3000 in 250 patients. The second study, conducted over 24 weeks, compared MED3000 with oral tadalafil, a commonly used ED medication, in a randomized, open-label trial of 96 patients.
Results from the studies found that 60% of the patients treated with MED3000 experienced clinically significant improvements in their ED as measured by the International Index of Erectile Function Erectile Function (IIEF-EF) domain. Notably, MED3000 facilitated rapid effects, with 60.1% of participants in the first study and 44.9% in the second study achieving erections in less than 10 minutes.
MED3000 was found to have a favorable safety profile, presenting low risks of local and systemic side effects, making it a viable option for men who are unable to use oral phosphodiesterase type 5 (PDE5) inhibitors due to contraindications, intolerance to side effects, or suboptimal responses.
The availability of MED3000 as an over-the-counter treatment is expected to enhance access to effective and safe therapeutic options, benefiting patients affected by ED who might otherwise avoid seeking treatment. The treatment is not yet available in the US.
This study was funded by Futura Medical Developments Limited.
