Promising results have been presented from clinical trials into a new spray to treat premature ejaculation. The researchers testing the new treatment say that is could help men suffering from P.E last 6 times longer.

That said, men who used the spray lasted an average of 3 minutes, compared with just over 30 seconds when they did not use it. Premature ejaculation is defined as ejaculation that occurs within one minute of vaginal penetration and is thought to affect up to 30% of men.

The spray, currently known as PDS502, is sprayed on the penis before sex. It is being developed by Shionagi Pharma Inc, who pay the leader of the clinical trial as a consultant. Ira Sharlip, clinical professor of urology at the University of California, has said that he is particularly excited to be involved in rigorous clinical trials for a P.E project.

Though Priligy, Jansenn-Cilag’s new pill for premature ejaculation, has been rigorously trialed, generally products sold as premature ejaculation cures promise amazing things but have little scientific data to back them up.

There have been two pivotal trials into PSD502, involving 530 men with premature ejaculation in total. They were either given a placebo spray or the real medication and were asked to administer 3 sprays to the penis, which was then wiped off before penetration. The spray contains two topical painkillers, lidocaine and prilocaine, and is described as ‘oily but not unpleasantly so’.

The men were asked to calculate their intercourse times (using a stopwatch – erotic!) and as well as reporting longer-lasting erection times, they also said that they experienced better ejaculatory control.

There were however side effects reported by their partners, with the most frequent being burning in the vaginal area.

The company are planning on applying for FDA approval in the near future.

One of the largest ever public surveys into premature ejaculation has shown that men are deeply reluctant to seek help for the condition, though it causes them great suffering and can put unbearable strain on their relationships.

Janssen-Cilag, who have developed the first ever pill for the condition, commissioned the survey, which saw over 4,500 men from 9 European countries asked about how premature ejaculation impacted on their lives and what they thought attitudes were to the condition.

The survey was also supported by various sexual health charities and support groups for men suffering from erectile dysfunction, including the European Sexual Health Alliance and the European Men’s Health Forum.

1 in 3 men said that the condition made them feel angry, ashamed or depressed while half of the men revealed that they felt to blame for it, which in turn made them feel guilty. Half also said that they have never discussed the condition with anyone, even their partners, with some suffering in silence for over 25 years.

Dr. Ian Banks, President of the European Men’s Health Forum, said that the survey clearly revealed that the condition was still a taboo subject, with the stigma attached to it preventing many men from talking and talking action .

Only 1 in 10 men said they had spoken to a healthcare professional about the problem, with half of those who had not saying they felt too embarrassed and 28% saying they did not consider it to be a medical problem.

With premature ejaculation the most common sexual problem reported by men, the study is a distressing indication how many men endure the condition alone and unsupported. It is to be devoutly hoped that the development of a medication to treat the disorder will lead to it being discussed openly and unashamedly, as happened with Viagra and erectile dysfunction.

With Johnson and Johnson still waiting for approval from the FDA for their premature ejaculation pill Priligy in the U.S, they are not going to be best pleased by the news that an Atlanta firm is also planning on seeking approval for an aerosol designed to combat the same condition.

Sciele Pharma has developed a metered-dose aerosol spray which when sprayed onto the skin is meant to increase latency time.  If approved, it will go head-to-head with Priligy to conquer the P.E market, which could be extremely lucrative.

A representative from the company, Joseph T Schepers, told the New York Times that premature ejaculation was in fact more common that erectile dysfunction (characterised by an inability to achieve an erection sufficient for penetration, rather than an inability to control ejaculation)  with 1 in 3 men suffering from it.

While there has been a certain amount of debate about whether premature ejaculation merits medical intervention, the International Society for Sexual Medicine defines it as ‘characterised by ejaculation which always or nearly always occurs prior to or within one minute of vaginal penetration’. They added that sufferers experience feelings of distress and feel out of control.

Dr. Wayne J. G. Hellstrom, a Professor of Urology at the School of Medicine at Tulane University and sometime consultant for Johnson and Johnson, said that men suffering from the condition often don’t manage to maintain relationships .

He has suggested that some 20 to 30% of men will experience the problem, meaning that for Johnson and Johnson and Sciele there is a very large market who would be interested in their product.

Scientists have called for companies launching clinical trials into premature ejaculation and erectile dysfunction to develop consensus standards in the area.

A review presented to the International Consultation on Sexual Medicine examined clinical trials into sexual dysfunction, focusing on those done over the past 20 years. They have said that future clinical trials need to have standards which would allow investigators to better conduct new trials in the field or consider evidence already gathered.

While there have been comparative studies into erectile dysfunction medications already on the market, an increased interest in premature ejaculation from pharmaceutical firms means that there are a growing number of trials into the condition.

Jannsen Cilag have already completed their trials for the premature ejaculation pill Priligy, the first pill to be approved for treatment of the condition.

However other firms are investigating potential treatments, such as topical sprays and injections.

One of the main difficulties facing scientists researching premature ejaculation is that it is even difficult to define the condition. A research paper presented at the European Society for Sexual Medicine reported that on average men with P.E lasted 1.8 minutes, compared to so-called normal men who lasted 7.3 minutes. However men with far longer lasting times have said they believe they suffer from the condition.

Jannsen accept the definition of the International Society of Sexual Medicine for the condition, namely that it involves a short time to ejaculation, lack of ejaculatory control and negative personal impact or distress related to ejaculation.

As their product Priligy is expected to be shortly available in the UK, this definition could be of use to doctors when deciding whether or not to prescribe the drug. However the vagueness of the definition demonstrates that for companies seeking to prove whether their medication helps treat the condition, there need to be very specific standards to prove efficacy.

Even although Priligy, the new premature ejaculation treatment from Johnson and Johnson, is not yet available in the UK, counterfeiters have already jumped on the bandwagon, claiming to sell the medication.

The drug has received marketing approval in Finland and Sweden so is available in both those countries. Marketing authorisation is expected to follow in a variety of other European countries after the European Medicines Agency approved the treatment. The Federal Food and Drug Administration is also considering an application for approval.

Priligy is not yet on sale in the majority of the EU countries and Johnson and Johnson themselves have warned that a number of websites are purporting to sell the medication.

They have notified government officials worldwide that counterfeit versions of the product have been sold, as well as informing them of the risks associated with counterfeit prescription drugs, including the risk of death. They also warned consumers only to buy the medication from a pharmacy officially licensed with government regulators.

Unfortunately, products associated with erectile dysfunction have already proved to be a rich target for illegal groups. Many men are too embarrassed to visit their doctor to discuss the problem, so resort to the internet to buy products anonymously. Viagra manufacturers Pfizer have expended considerable efforts towards making men more aware of the dangers and it looks like it will be a key concern for Johnson and Johnson too.

Fairly depressing to think that companies are already claiming to sell a medication before it has even gone on sale legally!