Futura Medical’s fast-acting topical erectile dysfunction drug MED2005 shows potential as a first-line treatment, following publication of Phase II trial data in the Journal of Sexual Medicine. MED2005 delivers encouraging results with rapid onset of action, significant improvements in Erectile Function scores, and a favourable safety profile.
MED2005 is a topical gel applied directly to the glans of the penis that contains 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 of 230 men with confirmed ED demonstrated that treatment with MED2005 significantly improved their International Index of Erectile Function-Erectile Function (IIEF-EF) score, the gold standard for efficacy measures in ED2 (p=0.0132). 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.
Futura Medical, a pharmaceutical company that focuses on innovative transdermal drug delivery technology, is developing a portfolio of sexual health products with a view to licensing the sales and marketing of these products to major pharmaceutical and healthcare groups.
James Barder CEO, Futura Medical said: “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. 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.”
During 2018 Futura Medical will commence a Phase III trial programme to evaluate the safety and efficacy profile of the product at varying dose levels in a larger patient population. Higher doses will be trialled to improve the clinical significance in cases of moderate and severe ED.
The full paper may be accessed from http://www.jsm.jsexmed.org/article/S1743- 6095(17)31852-0/fulltext