A new condom which aims to help men who cannot keep an erection while wearing a condom is nearing regulatory approval in Europe.
“The market they’re aiming for isn’t just men with decreased erectile performance, it’s the guys who perform well enough, but lose the erection while they’re putting on the condom, which is a sizeable number of men,” explained Dr. Keith Jarvi, chief of staff, urology at Mr. Sinai Hospital and professor of surgery at the University of Toronto.
He was unable to give a number on the amount of men he was speaking about, since he usually seems men “who are at the end of the line” and cannot have an erection at all.
Developed by Futura Medical, the condom does not actually contain sildenafil, which is the active ingredient in Viagra. Instead, it has a gel called Zanifi in it which, when the condom is applied, acts as a vasodilator and enhances erections, making them firmer and longer lasting. Viagra, and other erectile dysfunction drugs, work in a similar fashion, by dilating blood vessels to allow more blood to flow through.
“The challenge is having a stable product in a condom — a gel that doesn't do anything detrimental to the condom,” Futura’s chief executive James Barder told the Wall Street Journal.
“Some products can degrade the latex very quickly. (The gel) has to be immobilized in the condom.”
The condom is being classified as a medical device in the U.K, which means it can be sold over the counter. It could be on store shelves as soon as the end of the year. Futura has a global distribution deal for the condom with the Reckitt Benckiser Group, which owns the condom brand Durex.
There has been mixed reaction to the condom. Some welcome a possible new tool to fight erectile dysfunction, while others worry about potential side effects.
“The thing that struck me just off the top was I thought: ‘Wow that’s an interesting and novel idea,’ and it may promote condom use,” said Shannon Griffin, men’s health associate at the Men’s Health Initiative of B.C.
Griffin has concerns about the active ingredients in the gel possibly conflicting with other health conditions or drugs. Especially if neither partner read the instructions to see if there is a possibility for contraindications. A contraindication is when a patient should not take a certain medication due to a health problem (e.g. a heart condition) or a possible drug interaction.
Jarvi said he is not too concerned with possible contraindications. “My bet is that it’s going to be very local (the drug just affects the penis), then the risk will be very low. (But), you can’t tell until you see all the studies on it,” he said.
The current comparison to Viagra would definitely interest people in trying the condom, which may increase condom use, Griffin said.
“It would be something that people would certainly want to try, to see what the effects would be, they’d be curious,” she said.
Jarvi called the possibility of the product increasing condom use a “secondary gain.”
“I think if it’s effective, it will. It’s certainly an interesting idea. It all depends what their costs are, but I think it’s got a very good chance to do that.”
Even if the condom gets regulatory approval in Europe this year, it doesn’t mean we will see it on store shelves here in Canada.
Griffin said she is interested to see where the condom goes from here — especially if and when the company tries to get approval in the North American market.
“In my experience, it’s more difficult to get approval over here in the States and in Canada. So that will be interesting,” she said.
The approval process in the U.S. and Canada could take years, both Jarvi and Griffin surmise.
In an email to the Star, Health Canada could not say whether the condom is being considered for sale in Canada.
“Until a product is approved for sale in Canada, Health Canada does not have the legal authority to make public the fact that a submission may have been filed or any other information related to the submission,” the statement said.
While condoms are regulated as a medical device in Canada, it still would need to be determined whether the product would be sold over-the-counter or by prescription.
“As part of the device licence application, the manufacturer would need to provide safety and effectiveness information to support the use of the medicinal ingredients supplied in the condom,” Health Canada said.
For Jarvi, the condom is just the latest example of the evolution in the erectile dysfunction industry.
“Just think, 15 years ago, we didn’t have Viagra, and even 20 years ago we didn’t have the injectables. So 20-25 years ago, it was basically penile prosthesis or nothing.
“There’s been a huge, huge evolution in the technology that’s been available. It’s been amazing to see it.”