PSSD Forum

BRITISH scientists have invented a non-drug gel for erectile dysfunction that could be on the market later this year. It contains only alcohol and water and works in just five to 10 minutes, according to researchers who trialled it on 1,000 men across Europe.

You put a small blob of it on the end of the penis and rub it in for 15 seconds. First, the user feels a cool sensation, then it warms up. In a few minutes, men report that they start to get an erection.

Regulators in Europe are close to approving an unusual over-the-counter treatment for erectile dysfunction (ED): a non-medicated gel that once was used as a placebo, but turned out to work just as well as the agent that was actually being tested. Meanwhile, the FDA just gave the OK for a trial of the treatment to start.

Research has suggested that the gel can spur erections within minutes in some patients after it is applied to the head of the penis. If it actually works, the gel -- technically a medical device, not a drug -- could be the biggest advance in ED since the advent of Viagra-type drugs in the late 1990s and early 2000s.

The company said that 60% of participants began to experience erections within 5-10 minutes of applying the placebo. Side effects were rare, with headaches (2.8%) and penile burning (1.2%) reported, they added.

An anonymous blogger known as Neuroskeptic cast doubt on MED3000 in a March post, noting that the gel "has never been shown to be more effective than any control treatment -- because it was the control treatment ... Overall, I don't think anyone knows how well MED3000 will work if it makes it to market. If it works, I don't think anyone could say how it works -- whether it be the placebo effect, evaporation, or just, well, mechanical stimulation."

Featuring Futura’s DermaSys drug delivery technology, MED3000 is designed to stimulate nerve sensors when applied to the head of the penis, leading to smooth muscle relaxation, tumescence and erection. In the phase 3 study, investigators randomized 96 men clinically diagnosed with mild, moderate or severe erectile dysfunction to use MED3000 or oral tadalafil, the active ingredient in Eli Lilly’s Cialis.

After 24 weeks, Futura saw a statistically significant improvement from baseline in erectile dysfunction, as measured using the International Index of Erectile Function (IIEF-EF) questionnaire, causing the trial to hit one of its co-primary endpoints.

The other co-primary endpoint showed that participants experienced an average change from baseline on the IIEF-EF score of 5.73 units, exceeding the 4-unit difference on which Futura said it agreed with the FDA. MED3000 outperformed tadalafil in terms of speed of onset of action, leading Futura to talk up the prospect of it making a claim such as “helps you get an erection within 10 minutes.”

Futura reported tolerability advantages of MED3000 over tadalafil, such as the reduced frequency of headaches, but in other regards the oral therapy performed better. “Overall tadalafil showed a greater improvement in erectile function than MED3000,” Futura said in a statement.