A novel topical treatment for erectile dysfunction (ED) has shown promising results in Phase II clinical trials, potentially offering a fast-acting alternative to existing therapies. MED2005, developed by Futura Medical, combines glyceryl trinitrate with the company's proprietary DermaSys® technology for enhanced topical absorption.
Clinical Trial Results Show Rapid Onset and Significant Efficacy
The Phase II study, published in the Journal of Sexual Medicine, enrolled 230 men with confirmed ED. Results demonstrated statistically significant improvements in the International Index of Erectile Function-Erectile Function (IIEF-EF) score (p=0.0132), widely recognized as the gold standard for measuring ED treatment efficacy. Notably, 70% of participants experienced onset of action within 10 minutes of application, addressing a crucial need for spontaneity in intimate relationships.
Safety Profile and Administration
MED2005 is applied directly to the glans of the penis as a 0.2% w/w glyceryl trinitrate gel. The treatment demonstrated exceptional tolerability, with no serious adverse events reported in either the treated men or their partners. Importantly, no participants withdrew from the study due to adverse events, suggesting a favorable safety profile that could support both prescription and over-the-counter use.
Expert Perspectives
"MED2005 has the required efficacy, speed of onset and safety profile consistent for an over-the-counter as well as prescription use product," stated Professor David Ralph, Consultant Urologist at St Peter's Andrology Centre & Institute of Urology, UCLH, London, and past President of the European Society of Sexual Medicine. "MED2005, for the first time in the treatment of ED, has the potential to meet the needs of primary care providers and of patients."
James Barder, CEO of Futura Medical, expressed optimism about the treatment's potential: "We are extremely encouraged by this Phase II data and in particular the rapid onset of MED2005 which can help restore spontaneity and greater intimacy for men with erectile dysfunction."
Future Development Plans
Building on these promising results, Futura Medical has announced plans to initiate a Phase III trial program in 2018. The upcoming studies will evaluate various dose levels in a larger patient population, with particular attention to higher doses that may improve clinical outcomes in moderate and severe ED cases. The company is actively pursuing discussions with potential licensing partners to advance the commercialization of this innovative treatment.
