A nitroglycerin-based topical gel known as MED2002 is fast-acting and widely effective, based on a series of clinical trials. If approved by regulatory authorities, it could provide stiff competition to oral ED medications such as Viagra.
British researchers in April 2018 wrapped up yet another round of late-stage clinical trials on a fast-acting topical gel that could soon be stealing market share from Viagra and other oral erectile dysfunction medications.
The topical gel, code named MED2002 by Futura Medical, the small British biotech company that developed it, can produce an erection in five to 10 minutes, far more rapidly than the 30 to 60 minutes it takes the oral drugs to produce the same results, according to the company.
Unlike Viagra and other such drugs, this topical gel can be used by men who take nitrate-based drugs for the treatment of angina and high blood pressure. The oral medications cause a systemic drop in blood pressure, which when combined with the effects of nitrate-based drugs can cause a life-threatening decline in blood pressure.
Will Be Marketed as Eroxon
In late-2016 clinical trials, Futura’s topical gel, destined to be marketed under the brand name Eroxon in some European markets, was tested on 232 men suffering from varying degrees of erectile function. Eighty-two percent of patients with mild ED developed erections within 10 minutes of application, while 54 percent of those with mild symptoms of impotence got the desired results in five minutes or less.
The active ingredient in the topical gel is glyceryl trinitate, a vasodilating drug that causes the blood vessels within the penis to expand, thus sharply increasing blood flow into the organ. Erection occurs when blood engorges the spongy erectile tissue in the corpora cavernosa, the twin cylinders of erectile tissue inside the penis.
Active Ingredient Isn’t New
Glyceryl trinitrate, also known as nitroglycerin, has been in use since the late 19th century. In oral form, it is most often seen as a small tablet that can be placed beneath the tongue where it rapidly dissolves, causing blood vessels to dilate and relieving the chest pain of angina, caused by insufficient blood flow to the heart.
The key to Eroxon’s effectiveness is the transdermal delivery technology developed by Futura. The company’s patented DermaSys skin delivery technology allows the nitrate-based drug to be delivered effectively and rapidly through the skin. Because the gel is applied directly to the penis, its effects are largely confined to that organ with little to no systemic uptake.
Outperforms Other Systems
James Barder, chief executive officer of Futura, said that DermaSys outperforms other transdermal delivery systems, acting almost as effectively as an injection of the drug directly into the penis itself. He pointed out that most topical gels and creams deliver only 10 to 15 percent of the active ingredient into the targeted area. “The advantage of DermaSys is that we can have a very low dose in the gel but drive it efficiently through the skin.”
As previously noted, Eroxon can be used by men who are taking drugs, such as nitrates, known to interact adversely with Viagra and the other oral ED medications. Those drugs cause a system-wide lowering of blood pressure, while Eroxon’s effects are confined largely to the penis.
No Major Safety Concerns
In its press release, Futura noted that no major safety concerns were identified during the recently completed clinical trials. It went on to state that “no serious adverse events or serious adverse reactions were recorded and there were no dropouts from the study owing to side-effect issues.”
Because of its quick onset of action, Eroxon gel can be applied just before intimacy, and its application to the penis can even be incorporated into foreplay. According to Barder, one of the biggest complaints about the oral ED drugs is the time that it takes for them to become effective, thus requiring advance planning, which tends to kill the sense of spontaneity.
US Survey Conducted
Barder said that in advance of its clinical trials, Futura conducted a survey of both patients and doctors in the United States to learn more about their feelings of dissatisfaction with the oral ED drugs. He said that 20 to 30 percent of the respondents said their main gripe was the need to plan ahead.
Futura’s topical gel is applied directly to the glans, or head of the penis. As its active ingredient is absorbed, the glyceryl trinitrate expands the arteries that supply blood to the penis, thus facilitating erection. Men using the gel will still have to rely on sexual stimulation to actually trigger the beginning of the erectile process, as is also the case with the oral ED drugs. Neither of these types of medications can deliver spontaneous erections.
Will It Work for More Severe ED?
It should be noted that the high degree of success in the clinical trials was observed only among men with mild symptoms of erectile dysfunction. The amount of the active ingredient used in the gel for the clinical trials was extremely low. It remains to be seen whether increased levels of the glyceryl trinitrate will extend the gel’s benefits to men with more advanced cases of ED.
The only form of the product already on the market is a condom coated inside with a different formulation of Eroxon designed to help the condom wearer maintain his erection. This product is on sale in the Netherlands under the brand name Blue Diamond.
UK, US Talks Underway
Futura officials are engaged in talks with regulatory officials in both the United Kingdom and the United States. These discussions are designed to formulate a plan to win approval for the topical gel and bring it to market, if approved. Company officials say that the gel would probably become available in the United Kingdom before debuting elsewhere. It’s also possible, according to company spokesmen, that the product in Britain could be sold over the counter. Eroxon’s introduction in the U.K. and elsewhere in Northern Europe should occur within the next 12 to 18 months, according to Futura spokesmen.
In the meantime, men with erection problems will have to rely on the oral ED drugs, which have proved effective and safe in the vast majority of men with whom the drugs have been tested. If the convenience of ordering your ED drugs online appeals to you, check out all the services offered by eDrugstore.com, a longtime online facilitator. To learn more, visit eDrugstore’s Erection Problems page.
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