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.
MED2002 will undergo clinical trials during 2015. The study, which will take place in the UK, is expected to commence in Q1 2015 and report in Q4 2015. The CRO for this study is the same CRO that conducted the successful pivotal study for CSD500 and shares the same active ingredient as MED2002. In contrast to CSD500.
Approximately 140 patients with ED will participate in the study, which will be a randomised, placebo-controlled, double blind, home use, cross-over design. The primary outcome of the study is statistically significant efficacy. 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, is advising the Company on the design of the study and development of MED2002.
In addition to undergoing clinical trials we have also established that MED2002 can be prescribed initially as a special product. MED2002 meets the criteria required within the UK for special product status because of the estimated 7.5% of ED sufferers who cannot be prescribed PDE5 inhibitors (products such as Viagra®) due to contra-indications with other medications taken by them. We have already identified a specials distributor and we expect that MED2002 will be available to UK doctors as a special product in 2015.
MED2002 describes all Futura's different gel formulations applied directly to the penis for the treatment of men with erectile dysfunction. Futura may code certain formulations, for identification purposes, by altering the final digit, eg. MED2001 or MED2004.