Futura Medical plans to seek approval of its patented DermaSys drug delivery system as a treatment for erectile dysfunction. Study participants given placebo via DermaSys had as positive a response in erectile function as those who got the active ingredients.
Futura Medical, a pharmaceutical company based in the United Kingdom, has come up with a novel proposal for the treatment of erectile dysfunction, according to an article posted at MedicalDevice-Network.com. And that proposal arises from clinical tests showing that its MED2005 topical gel failed to significantly outperform a placebo that used the identical delivery system on study participants.
So, left with lemons in the wake of these disappointing results, Futura Medical wants to make lemonade. It now hopes to market the placebo or, more specifically, the drug delivery system itself, which is known as DermaSys. After all, that delivery system managed to deliver promising results all on its own.
It’s a Topical Gel
Futura’s originally proposed erectile dysfunction drug is a topical gel that contains glyceryl trinitrate, a drug designed to temporarily improve blood flow to the penis. However, during phase three clinical testing, study participants were divided into two roughly equal groups. One received the gel containing the active ingredient glyceryl trinitrate. The second, known as the control group, got the same gel but without the active ingredient designed specifically to combat ED.
Surprisingly, 60 percent of those in the control group were able to achieve an erection within 10 minutes after applying the gel. This was a result almost identical to the one experienced by study participants who were given the gel containing glyceryl trinitrate. And a 10-minute onset of action is significantly faster than those typically experienced by the users of oral ED medications such as Viagra and Cialis.
CEO Hails DermaSys Performance
In the wake of phase three clinical testing, James Barder, Futura’s chief executive officer, expressed disappointment that MED2005 failed to outperform a placebo. However, he said, “We are excited that DermaSys alone has achieved such statistical significance in meeting all the primary endpoints against the baseline and key secondary endpoints using validated and globally accepted measurement tools.”
That surprisingly positive performance by the drug delivery system alone has convinced Futura to advance DermaSys itself as a “clinically proven” treatment for ED. Barder said the clinical test results provide the company with a “potentially simpler regulatory pathway” to win approval for DermaSys as a medical device rather than MED2005 as a drug.
Plan Has a Way to Go Before Approval
Whether the U.S. Food and Drug Administration will see things the way Futura does remains to be seen. In the meantime, this novel approach to ED treatment is just a promising idea that has not moved much beyond the talking stage.
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