MED2002 will be a 'rub-on' gel applied directly to the penis for the treatment of male erectile dysfunction (ED).
MED2002 is based on the active compound Glyceryl Trinitrate within a patented gel delivery system. 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.
MED2002 is expected to become the world's first non-prescription pharmaceutical treatment for men with ED. By being available from pharmacies without the need for a doctor's prescription, MED2002 will be aimed at satisfying a large unmet demand from men with ED.
Futura and SSL International have signed a global development and licensing agreement for the worldwide rights to MED2002.
Under the terms of the agreement with SSL, an undisclosed royalty on MED2002’s sales will be paid to Futura with milestone payments of up to £18 million, subject to certain specified regulatory approvals and sales targets being achieved. SSL and Futura will jointly manage the completion of the clinical development programme of MED2002 currently expected to cost up to £3.65 million, with SSL contributing 65 per cent of the costs and Futura contributing 35 per cent.
A double blind placebo controlled pivotal study for over 200 men with erectile dysfunction is shortly to commence in Germany and Greece. The study has been powered to give statistically significant efficacy data as well as safety data and the results are expected by the end of 2008.
This agreement with SSL further strengthens the existing relationship between Futura and SSL, which already holds the distribution rights for two of Futura’s products currently under development.
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.
Working in partnership with
MED2002 utilises our skin delivery technology
