The European Commission granted permission for Fortacin to be used in the European Union in November 2016. It will be available on prescription, initially in the United Kingdom, and later in other countries.
Below is my original article, written some time ago now when the spray first appeared in the news, but still wasn’t available.
The background to Fortacin
I’ve been doing some research to find out when Fortacin – previously known as PSD502 spray or Tempe – might become available. I’ve also been looking into how well it worked in tests and what alternatives there are.
PSD 502 spray hit the news in 2010 with various claims it could be the premature ejaculation treatment guys have been waiting for. Some articles claimed it helped men last up to 6 times longer.
Apparently it helped men with life-long severe premature ejaculation go from under 1 minute to lasting up to 4 minutes on average.
But since 2010 it seems to have disappeared from the news. It’s now 2016 and there still haven’t been any obvious major updates other than a renaming to Fortacin. My guess was that it was still undergoing testing and yet to be approved by the United States Food And Drugs Administration (FDA).
But guesswork isn’t enough, so I decided to investigate how this wonder drug got lost in time. I eventually discovered that as with so many drugs, the development company has changed. And that there are now some estimates of when it may actually be available.
Investigating when PSD 502 will be available
A phone call to Shionogi Inc
The company which published the news about PSD502 spray in 2010 was Shionogi & CO., ltd. They are a global pharmaceutical company based in Japan but with branches in several countries.
They have absolutely no information on their US based website about PSD502. So a while back in 2014 I decided to phone them to ask them about it.
I was informed that as soon as there was any news it would appear on the various Shionogi websites. Importantly it’s still unapproved and undergoing stage III testing in the US.
Checking the Japanese website for Shionogi & CO., LTD
Fortunately there was more information on the main Shionogi & CO., ltd website in Japan. They actually list PSD502 spray as being in stage III testing in the US. You can also still find their original press releases from 2010.
Interestingly they also say it’s now being developed by a combination of Shionogi and Plethora Solutions Holdings PLC in the UK.
A press release in August 2013 from Plethora
A quick check of the Plethora Solutions website finally revealed an interesting press release in 2013 about PSD502 spray.
They say that Plethora entered into an agreement with Shionogi to take responsibility for getting PSD502 approved globally. Plethora had already been trying to achieve approval in Europe since 2011. And with full responsibility they now have some estimates of when you might be able to buy PSD502.
Dates when it may be approved
These are the main points to take away from the Plethora press release regarding approval:
- They are hoping to get a response from the European Medicines Agency (EMA) in late 2013.
- They intend to re-apply to the FDA for approval in the first half of 2014. Evidently it wasn’t approved by the FDA the first time round.
- If all goes smoothly and the FDA approve it, PSD502 spray could be available in the United States in 2015.
Well, it’s now 2016 (I first wrote this article in 2014 and have come back to check on the spray several times in updates). It’s still not available, and a recent check in May 2016 discovered that the main website for the spray seems to be advertising it for potential buyers. I guess they still haven’t got the approval they were hoping for.
What is PSD 502 and how does it work?
Psd 502 is a topical anesthetic spray which is being developed to numb the penis and help treat premature ejaculation. It has two principle ingredients, Lidocaine and Prilocaine.
Lidocaine is commonly used in many other types of delay sprays and even in condoms. It’s thought that the addition of Prilocaine is one of the reasons they are struggling to get it approved. Mainly because Lidocaine is available over the counter in most countries, but Prilocaine isn’t.
It will be in a metered aerosol spray, meaning that every spray should provide the same quantity. This makes it easier than creams for example to get the right amount and not over-numb the penis.
A major selling point will be how fast it acts. Studies show that just 5 to 10 minutes before having sex is enough for it to take action.
It’s one of only two sprays which are specially designed to penetrate the surface of the skin effectively. The idea being that it will help reduce the sensitivity of the penis during sex, but at the same time reduce the risk of being numbed so much that you can’t enjoy it. And importantly to reduce the risk of it transferring to a partner.
The only other spray which does this is Promescent, which has been approved by the FDA in the United States. You can find more about that at the end of this article.
How effective is it?
This is the most important question – does PSD 502 work, and if so how well? Is it the premature ejaculation cure guys have been praying for?
The simple answer is that according to trials and research PSD502 spray does seem to work. The more complex answer involves taking a look at how well it worked during those trials.
The results of two important phase III studies were published around 2010. This is where it’s actually fully tested on guys who have lifelong premature ejaculation. Not just on animals or at low doses to see if it causes side effects etc. Here’s a brief summary of the results:
The European phase III trials in 2009
300 men with lifelong premature ejaculation took part in the European trials. They had an overall average lasting time of 0.6 minutes to begin with.
86% of the participants rated the treatment as effective, with 66% saying it was good or excellent. It was found to help guys last up to 6.3 times longer on average.
They found the average lasting time during actual sex (the IELT – intravaginal ejaculatory latency time) went up to 3.8 minutes. This compared with 1.1 minute for guys on the placebo. The complete range of lasting times to make this average was between 0.3 minutes and 57.8 minutes!
They also importantly assessed guys’ feelings about sex when using the spray, finding the following:
- Guys felt better ejaculation control.
- They felt less distressed by their performance.
- They were more satisfied with their sex life.
- They had less relationship difficulties because of it.
- They felt they had better orgasms.
Only 2.6% of men reported any side effects, mainly the penis being too numb. Compared to many other delay products, this is a good result.
Phase III studies in the United States, Canada and Poland in 2010
In these tests of 256 men it was also found that PSD502 was effective. The initial average lasting time was 0.56 minutes, very similar to the European study.
The lasting time with the spray increased to 2.60 minutes. Compared to the placebo which only increased to 0.80 minutes you can see then a clear improvement overall.
Again like the European study they found an improvement in overall satisfaction. And again found that it was well tolerated with most guys not experiencing side effects.
So it works, but does it work well enough?
You can see then from these two large trials that PSD502 is effective in increasing lasting time. When you think about the phrase ‘6 times longer’ that makes it sound amazing.
But when you think that in reality that only means an extra 3 minutes for most guys, it hardly turns you into a super stud. But the difference between less than a minute and 3-4 minutes is admittedly impressive.
So I imagine when PSD502 is finally available to buy it will be up to individual guys to discover how well it works for them. Clearly some guys last much longer with the spray if 3 minutes is an average. And overall most guys are clearly happy with the improvement. But at the same time some guys might feel that just a couple of extra minutes is not enough.
In addition these trials were on guys with lifelong premature ejaculation. It’s not known how well it will work if you last a few minutes already but just want help to last even longer. It’s also not known how well it works on guys with acquired, or secondary, PE.
So overall you can see that PSD502 spray didn’t disappear from the news because it doesn’t work. It simply disappeared because it’s taking a long time to be approved for sale.
The company responsible was optimistic that at some time in 2014 or 2015 it would be available to buy in Europe and the United States. That didn’t happen though and it’s unclear if and when it will ever become available.
(as I mentioned at the start of this article, it is now available on prescription in the UK, with other EU countries to follow)
If you’re interested in using a delay spray, you might like to check out my review of the best delay sprays.