"Significant numbers of ED sufferers cannot be prescribed PDE5 inhibitors and, in addition, there is strong patient interest in effective alternative ED treatments with a rapid speed of onset. This makes MED2002 a potentially interesting product."
David Ralph BSc MS FRCS (Urol), Key Opinion Leader
MED2002 will be a topical gel applied directly to the penis for the treatment of male erectile dysfunction ("ED").
MED2002 is based on the active compound Glyceryl Trinitrate ("GTN") within a patented gel delivery system, DermaSys®. GTN is a potent vasodilator and has been used for the treatment of angina and associated cardio-vascular defects for more than 40 years, where it has been determined to be a safe and effective drug with a known side-effect profile.
MED2002 is applied to the glans area of the penis with a single dose applicator. DermaSys®, our skin delivery technology developed for MED2002, enables the active dose to be delivered effectively and rapidly through the skin. This topical application translates into a low systemic uptake which will help to reduce unwanted side effects and minimise the potential for adverse interaction with other centrally acting drugs such as PDE5 inhibitors Viagra®, Cialis® or Levitra®.
This is a less invasive method of application compared with other treatments and is consistent with sexual foreplay. The GTN is absorbed into the penile blood system and is converted to nitric oxide, having the effect of relaxing muscles surrounding the corpus cavernosa and dilating the penile arteries. This allows the corpus cavernosa to engorge with blood and, following sexual stimulation, a natural erection occurs.
We have conducted external market research to understand the potential opportunity that MED2002 represents as both a prescription and non-prescription treatment for erectile dysfunction in order to optimise the commercial opportunity. This market research highlighted the potential benefits of MED2002 when compared with PDE5 inhibitors. The potential benefits of MED2002 were shown to include: a faster onset of action, a favourable safety profile and the product's suitability for all men, including the estimated 7.5% of ED sufferers who would not be prescribed any of the PDE5 inhibitors due to contra-indications of other medications taken by them. The research found that up to 68% of men are dissatisfied with their PDE5 inhibitors and that MED2002 could potentially capture as much as a 30% share of ED patients.
A pivotal clinical efficacy study is now underway. The primary outcome of this clinical trial of 192 patients with ED, which will be a randomised, placebo-controlled, double blind, home use, crossover design, is to demonstrate statistically significant efficacy. The clinical trial is expected to report before the end of H1 2016. David Ralph, Past-President of the British Society for Sexual Medicine and currently vice President of the Sexual Dysfunction Association and President of the European Society for Sexual Medicine and a recognised key opinion leader, has advised the Company on the design of the study and development of MED2002.
We have out-licensed exclusive rights to Quantum Pharma plc for the manufacture and supply of MED2002 as an unlicensed medicine ("Special") in the UK. Quantum is the leading manufacturer and supplier of specials to retail pharmacies and wholesalers in the UK. In return, Futura will receive undisclosed royalty payments from Quantum on the sales of the product.
Specials are medicines that have not been authorised and which are requested and prescribed for the treatment on a named patient basis only by appropriately qualified doctors under their own authority. Such requests can only be made subject to a number of conditions being met including the absence of licensed alternatives.
MED2002 meets the UK regulatory criteria for a Special because of the estimated 7.5% of erectile dysfunction sufferers who cannot be prescribed PDE5 inhibitors, such as Viagra®, owing to contraindications with other medicines they take.