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Treatment for premature ejaculation

Gareth Malson reports on a new product for treating premature ejaculation

Who is it for?

Jim visits his GP with a sore toe. At the end of the consultation, he asks about treatment for erectile dysfunction. Further questioning determined that he was, in fact, suffering from premature ejaculation. His two previous relationships, each lasting several years, had ended because “the women just got fed up with him”. Since then, he has abandoned any hope of a long-term relationship. At this point, Jim breaks into tears.

Couple back-to-back in  bed (MartinMark/Dreamstime.com)

Pam visits her GP to complain of headaches. On further questioning, she bursts into tears, too — saying she is desperate to get pregnant. She had been trying for 18 months but, more often than not, her husband would “ejaculate on her thigh”. She loves him but is considering an affair with “a guy at work who looks like him” in order to get pregnant.

“Premature ejaculation can break up relationships and have a profound effect on people’s lives,” says David Edwards, a GP in Chipping Norton and president of the British Society of Sexual Medicine (BSSM). “Once a patient has been diagnosed with premature ejaculation, the first thing I do is reassure them of how common a problem it is. There are many treatment options available; an algorithm on the BSSM website offers a guide to which ones are appropriate.”

For some time, however, Lloydspharmacy has offered imported dapoxetine, a selective serotonin-reuptake inhibitor, on private prescription. “The fact that people are willing to spend so much on an imported treatment shows the extent to which this condition affects them,” Dr Edwards adds.

This treatment is now available in the UK (Priligy; Menarini) and can be prescribed on the NHS. Treatment is licensed for use in patients aged between 18 and 64 years of age. Patients should be diagnosed with premature ejaculation before they are prescribed dapoxetine. According to the drug’s licence, they should meet the following criteria:

  • An intravaginal ejaculatory latency time (IELT) of less than two minutes
  • Persistent ejaculation with minimal stimulation
  • Marked personal distress as a result of the condition
  • Poor control over ejaculation
  • The problem occurs during most attempts at intercourse

“Generally, patients will tell you when they think they’re suffering from premature ejaculation,” says Trudy Hannington, a psychosexual therapist from Doncaster. “However, you need to ensure their interpretation of the condition is correct. Some have unrealistic expectations of how long the penetrative part of sex should last and are often surprised to learn that the average is only around five minutes.”

How it works

According to the summary of product characteristics, human ejaculation is primarily mediated by the sympathetic nervous system and the relevant pathway originates from a spinal reflex centre and is mediated by the  brain stem. The mechanism of action of dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the potentiation of its action at pre- and postsynaptic receptors.

SSRIs, particularly sertraline and paroxetine, have long been used as treatments for premature ejaculation. “These are not ideal; they are not licensed for premature ejaculation, they act for longer than necessary and can’t be used on an ‘as required’ basis,” explains Dr Edwards. “Dapoxetine has a faster onset and shorter duration of action. This, and the fact that it’s licensed to treat premature ejaculation, gives it an advantage over other SSRIs.”

Treating patients for premature ejaculation

Premature ejaculation is defined as the male ejaculating too quickly during sexual intercourse but, many men are unsure about how long sex should last before ejaculation. A study looking at 500 couples from five different countries found the average time between a man putting his penis into his partner’s vagina and ejaculation was around five-and-a-half minutes.2

According to surveys about one in three men have been affected by premature ejaculation but the true figure may be higher if men may be likely to be reluctant to report this problem.2

Psychosexual therapist Trudy Hannington tends to discuss all available treatments with her patients. “Letting patients know that there are lots of options available can provide reassurance if their first treatment is, or has been, unsuccessful. It also allows them to pick which ones are most suitable for them. Furthermore, the most successful treatment often involves a combination of factors.”

Other treatments for premature ejaculation include:

  • Selective serotinin-reuptake inhibitors — eg, sertraline, paroxetine (off-label use)
  • Topical anaesthetics — eg, Emla (off-label use)
  • Pelvic floor exercises (also known as Kegel exercises)
  • Behavioural therapies — eg, the start-stop technique or the squeeze technique
  • Masturbation techniques (these make the man more used to being sexually aroused)

Research

A review of five randomised, double-blind, placebo-controlled, phase III clinical trials has been conducted by a multinational group of researchers (Journal of Sexual Medicine 2011;8:524–39). In total, the studies included over 6,000 participants. The analysis found that, from an average baseline of 0.9 minutes, IELT increased to 3.1 minutes for dapoxetine 30mg and 3.6 minutes for dapoxetine 60mg. By comparison, patients receiving placebo increased their IELT to 1.9 minutes (P<0.001 when comparing either strength with placebo).

“Successful treatment will depend on the individual and patients should be given a clear indication of what are realistic expectations of treatment,” Mrs Hannington suggests. “Rather than aiming for a target duration for intercourse, treatment success should be gauged to whether the patient feels it is working and whether his confidence increases.”

Administration

Dapoxetine should be taken between one and three hours before sex. Patients should start on the 30mg dose. “You would review patients after a few weeks and hope to see an increase in IELT,” says Dr Edwards. “The dose can then be increased, if necessary, to 60mg.” According to the SPC, Priligy tablets should not be taken more frequently than one every 24 hours and the product is not intended for continuous daily use.

Alcohol should be avoided when taking dapoxetine due to an increased risk of side effects, such as syncope. “This could prove an issue for some patients — however, they must be warned of this risk,” says Mrs Hannington.

Safety

“Before taking dapoxetine, men need to make sure they are well hydrated,” Dr Edwards points out. “They should be advised to take each tablet with a full glass of water. The drug  can also cause nausea and vomiting, although this effect tends to be less profound than for other SSRIs.” The patient information leaflet explains that taking the medicine with plenty of water may lower the chances of fainting and low blood pressure.

The product’s SPC also lists headache and dizziness as common side effects and, since sleepiness has also been reported, patients should be advised to exercise caution if driving or operating machinery.

Dapoxetine is metabolised by CYP2D6, CYP3A4 and flavine mono-oxygenase enzymes. Inhibitors of these can reduce clearance of the drug. Concomitant use of potent CYP3A4 inhibitors is contraindicated.It should also not be used with phosphodiesterase-5 inhibitors.

The SPC states that “animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy or embryonal/fetal development”.

Cost

From UK wholesalers, now without the need for importing, the basic price of dapoxetine (excluding VAT) will be:

  • 3 x 30mg tablets £14.71; 6 x 30mg tablets £26.48
  • 3 x 60mg tablets £19.12; 6 x 60mg tablets £34.42

This represents a considerable reduction from the price charged by Lloydspharmacy for the imported product (from £64 for three tablets).1

Place in therapy

Now that it is readily available in the UK, Dr Edwards expects dapoxetine to become his SSRI of choice when treating premature ejaculation. Furthermore, regardless of whether its use becomes restricted on the NHS, he thinks men affected by premature ejaculation will be happy to pay for a private prescription.

“I think men will be happy to pay for treatment if it is priced at about the same amount as phosphodiesterase-5 inhibitors. I am concerned, however, that if it isn’t available on the NHS it will encourage men to purchase the drug online — encouraging counterfeit drug sales and putting men’s health at potential risk.”

Mrs Hannington hopes that anyone who takes the drug has the opportunity to access psychological support. “When prescribed dapoxetine, pharmacists could advise patients that treatment will be more effective if guided by a therapist and combined with other non-pharmaceutical treatments,” she suggests. “Details of local sexual health services should be available from the local genito-urinary medicine clinic.” Contact details for local sexual and relationship therapists can be found at the College of Sexual and Relationship Therapists website.

Key points

  • Dapoxetine (Priligy) is a selective serotonin-reuptake inhibitor licensed for treating premature ejaculation.
  • It is taken one to three hours before sex. It is not intended to be taken more frequently than once every 24 hours. Patients should be advised to take the tablet with a full glass of water.

 

DECLARATIONS OF INTEREST David Edwards has sat on advisory boards for Menarini and received honararia for delivering educational talks. Trudy Hannington has conducted education meetings for the company.

 

References

  1. Lloydspharmacy Online Doctor Available at https://onlinedoctor.lloydspharmacy.com (accessed on 7 November 2013).
  2. NHS Choices. Ejaculation problems. Available at www.nhs.uk. (Accessed on 7 November 2013).

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11130193

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