MED2002 and MED2005 – Pros and Coins and Current State of Clinical Trials
MED2002 and its enhanced version, MED2005, are new nitroglycerin-based erectile dysfunction medications developed by British pharma company Futura Medical and currently going through Phase III clinical trial. They have been getting lots of media attention during the past few years with articles published in The Telegraph, Men’s Health, The Sun, etc. The interest is easy to explain – if the clinical trials prove its effectiveness, MED2002/2005 will become the first entirely new means of treating male impotence in over a decade.
The concept of using nitroglycerin also known as glycerin trinitrate to enhance sexual function in men is not new. There is a 1977 article by JW Mudd that described the positive outcomes of using nitroglycerin in patients with atherosclerotic impotence. A 1989 article by Owen et al proved that topical nitroglycerin also worked to trigger erections in men suffering from impotence and a 1997 article by Renganathan et al showed that topical nitroglycerin worked even in men with impotence due to spinal cord lesions.
The effect of topical nitroglycerin is due to its ability to convert to nitric oxide after being absorbed into the blood system. When applied to the penis, it relaxes the smooth muscles lining the blood vessels inside the penile body and allows more blood to enter resulting in an erection. Different versions of MED2002/2005 contain 0.2%, 0.4% and 0.6% of glycerin trinitrate. The medication also uses DermaSys – a patented component for enhancing delivery of active ingredients through the skin and into the blood system.
There is a topical form of nitroglycerin under the brand name Zanifil already approved for use and available for purchase in 27 countries of the world. It has also been invented by Futura Medical and is sold as gel added in small amounts into condoms of such brands as Blue Diamond, Durex Performax Intense, Futura Max Manex, etc. The erectogenic effect of Zanifil is proven by clinical studies. However, it is not an approved medication for treating impotent patients but rather a means of improving erection quality. There’s also an ongoing clinical trial aimed at evaluating the potential ability of Zanifil to increase sexual pleasure in women with results expected to be published in 2020.
MED2002 and MED2005, in their turn, are marketed as potential forms of treating impotence, not just enhancing erection quality. They are currently going through Phase III clinical trials with the results scheduled for release by the end of 2019. If the tests prove the efficacy of the medication, Futura Medical will do a confirmatory clinical trial in 2020 and is expected to release MED2002/2005 into the market in 2021.
According to the results of the past clinical trials, Futura Medical’s product shows limited efficacy in improving erectile function, which is what doctors like AD Seftel criticize it for. The patients taking part in the trials reported a mean increase in erectile function score of 2.5 points (from IIEF-EF 17.1 to 19.6). For comparison, the patients taking Cialis reported a mean increase from IIEF-EF 14.6 to 23.3 when taking the pill as needed. Only 23.1% of the patients using MED2005 report a clinically relevant increase in erectile function score, which means that this medication is not going to work for everyone. On the other hand, the people who respond to the treatment will benefit from shorter time to the onset of action (5-10 minutes compared to 30-60 minutes for PDE-5 inhibitors) and much lower incidence of side effects. The most commonly reported adverse reaction to MED2005 was headache experienced by just 7.9% of the patients. Another topical ED treatment, alprostadil cream, in its turn, causes adverse reaction in up to 78% of the patients. The use of MED2005 is non-invasive and not associated with any dietary restrictions.
All in all, MED2002/2005 is not likely to become one of the leaders in the erectile dysfunction market because of its comparatively low efficacy. However, there is still expected to be a sufficient demand for this product because it works faster than its alternatives, causes fewer side effects and allows for greater spontaneity in sex.
- The Telegraph on MED2002 - https://www.telegraph.co.uk
- Men’s Health on MED2002 - https://www.menshealth.com
- The Sun on MED 2002 - https://www.thesun.co.uk
- JW Mudd, Impotence responsive to nitroglycerin - https://www.ncbi.nlm.nih.gov
- JA Owen et al, Topical nitroglycerin to treat impotence - https://www.ncbi.nlm.nih.gov
- R Renganathan et al, Topical nitroglycerin vs papaverine injections in the treatment of impotence in men with spinal cord lesions - https://www.nature.com
- CSD500 availability worldwide - https://www.futuramedical.com
- CDS500 clinical studies results - http://www.bluediamondcondom.com
- Clinical trial researching the effect of Zanifil use in heterosexual women - https://clinicaltrials.gov
- AD Seftel, Criticism of MED2005 as a means of treating erectile dysfunction - https://www.auajournals.org
- DJ Ralph et al, Efficacy and safety of MED2005 - https://www.sciencedirect.com
- HH Sung, SW Lee, Efficacy of Cialis - https://www.ncbi.nlm.nih.gov