Trial data provides encouraging results for MED2005, says Futura Medical
Following the publication of Phase II trial data, Futura Medical announces encouraging results, significant improvements in erectile function scores and a favourable safety profile with its topical drug, MED2005.
MED2005 is a topical gel containing 0.2% w/w glyceryl trinitrate and DermaSys technology, an enhanced topical absorption system that facilitates rapid drug delivery across the skin barrier.
The Phase II trial included 230 men with confirmed erectile dysfunction (ED). It was found that treatment with MED2005 significantly improved their International Index of Erectile Function-Erectile Function (IIEF-EF) score. Onset of erection occurred within 10 minutes for 70% of participants on average. MED2005 was very well tolerated with no reported serious adverse events related to the treatment in men or their partners, and no withdrawals from the study due to adverse events.
“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,” explained James Barder CEO, Futura Medical. “The excellent safety profile allows us to explore higher dose levels to optimise the efficacy and safety profile of the product. We are also actively continuing our discussions to find the right licensing partner for this exciting product.”
Professor David Ralph consultant urologist at St Peter’s Andrology Centre & Institute of Urology, UCLH, London, past president of the European Society of Sexual Medicine, and study author said: “MED2005 has the required efficacy, speed of onset and safety profile consistent for an over-the-counter as well as prescription use product. MED2005, for the first time in the treatment of ED, has the potential to meet the needs of primary care providers and of patients.”
Futura Medical, based in Surrey UK, is a pharmaceutical company that develops products for both prescription and consumer healthcare markets.