Priligy is the latest lifestyle drug offering from Johnson and Johnson. Priligy is the trademark brand name for dapoxetine hydrochloride, and is an orally ingested drug used to treat erectile dysfunction. Erectile dysfunction, or ED, is more commonly referred to as premature ejaculation, and is estimated to affect 30% of the male population. Clinical trials have shown Priligy to be effective at increasing the length of sexual intercourse by between 200% and 300%.
Although Priligy is yet to receive Food and Drug Administration approval in the US, it is already approved in several European countries, including Sweden, Finland, Portugal, Spain, Italy, and Germany. It is expected that approval will be granted in the UK and the rest of Europe in the very near future.
History
Originally created by Eli Lilly, and credited to the biochemist David Wong, dapoxetine hydrochloride was an offshoot during the development of the antidepressant flouxetine (better known as Prozac). Dapoxetine, like the many other antidepressants available on the market today, is a dapoxetine is a selective serotonin re-uptake inhibitor (SSRI). At the time of its initial development, Ely Lilly actually began clinical trials for its use as an anti-depressant. While these trials failed, dapoxetine soon found another life as a treatment for PE.
In 1998, the rights to develop dapoxetine as a premature ejaculation treatment were sold to PPD GenuPro by Ely Lilly. In turn PPD GenuPro sold the global marketing rights for the drug to a Johnson and Johnson affiliate company, ALZA Corporation, in 2001. Eventually, PPD bought the dapoxetine patents from Ely Lilly in 2003, and will receive royalty payments on dapoxetine sales by the various Johnson & Johnson companies marketing the drug worldwide.
Approvals
Eli Lilly conducted phase I of the clinical trials for dapoxetine, during the search for an antidepressant drug. These were followed by phase II trials which were conducted with PPD GenuPro. In 2005, PPD presented the findings of two major phase III trials it had conducted. These showed that in a significant percentage of men aged between 18 and 65, 60mg-100mg doses of dapoxetine led to time to ejaculation during sexual intercourse increasing from less than a minute, to 2-3 minutes.
By 2008, more than 6,000 men had taken part in trials, which did find that there was an increase in time to ejaculation during sexual intercourse, and that the participants felt a greater sense of control over their ejaculation as well as experiencing greater sexual satisfaction.
The first FDA approval application was made in December 2004 by ALZA. This was rejected in October 2005 by the FDA, which issued a "not approvable" letter, and demanded further trials. Undeterred, Johnson & Johnson continued development of the drug. Clinical trials to establish and address any possible side effects and risks of dapoxetine use were initiated. Alongside this, Johnson & Johnson pursued approval of the drug in markets outside the US. One of their subsidiaries, Janssen-Clegg submitted an application in 2007 to market the drug in Europe, beginning in Sweden. By February 2009, approvals had been granted in Finland and Sweden, with other European countries following soon after.
Overview
One of the major criticisms of Priligy, has been that it is a cure looking for a problem. In part, this is due to the lack of a consistent definition of what premature ejaculation actually is. Attempts have been made to clarify this, with some of the consensus revolving around the problem as being "a man reaching orgasm before he would like to, causing frustration". This rather vague description is quite subjective, and will vary from man to man.
Attempts have also been made to quantify this 'problem', with researchers in the field describing it as an Intravaginal Ejaculatory Latency Time (IELT) of 2 minutes or less. By that definition, anyone who ejaculates within 2 minutes of entering the vagina, suffers from premature ejaculation, or PE. Estimates of the extent of this problem vary, with some studies putting them as high as 30%-40% of the population.
That said, Priligy primarily acts by altering the concentration of serotonin in the hypothalamus, giving the user more control over when he ejaculates. By increasing the amount of time that sexual intercourse takes place, it can be argued that Priligy is an effective treatment for PE.
Dosage
Priligy is prescribed as a pill, to be taken up to once daily, and between 1-3 hour before sex. The typical dosage for men between 18 and 64, is 30mg, although this can be increased to 60mg in men who are not seeing improvements at the lower dosage. Priligy is not suitable for men older than 64.
Like all medications, it can be unsafe to take Priligy in conjunction with other drugs, since they can affect the way it works. As an example, Priligy should not be taken with alcohol. The latter's effects can be amplified when taken with Priligy, and the risks of injury from fainting are increased. As always, it is important to check with the prescribing doctor before mixing a cocktail of drugs.
Common side effects
Some users have been found to suffer side effects when taking Priligy. Anyone noticing any side effects from taking the drug should inform their doctor as soon as possible, especially if these are severe.
Some of the more common side effects that have been observed in more than 10% patients include
- fainting when standing up
- dizziness
- headaches
- feelings of nausea
Less common effects, affecting less than 10% of users, include
- anxiety, restlessness and feeling irritated
- pins and needles, or numbness
- increased sweating
- general fatigue and constant yawning
- increased blood pressure
- loss of interest in sex, and erectile dysfunction
- nasal congestion
Far less common, are side effects affecting less than 1% of users. These include
- faecal urgency and diarrhoea
- suddenly falling asleep
- dizziness following exertion
It must be noted here that the list above is neither complete, exhaustive, nor is it indicative of the experiences of every Priligy user. All users therefore, are advised to check with their doctor before using the drug, and also at the appearance of any side effects.
Whether Priligy will eventually get FDA approval remains to be seen. Critics argue that the side effects of the drug far outweigh any potential benefits from increased IELT. Others still, argue that while there are many men who genuinely suffer from being unable to control their ejaculation, there is very little evidence to suggest that this is an epidemic problem. Supporters though, argue that the problem is real, that up to 40% of men suffer from this at some point in their life, and that it is a medical condition to be treated.
Irrespective of how these debates pan out though, dapoxetine is here now, and will soon be available at a pharmacy near you.
Do I need a prescription?
You do not
need a prescription from your GP, the prescription will be either issued or
declined after you have completed the medical questionnaire, it is in your own
interest and for your safety to answer the questions truthfully, if you are in
doubt please consult with your GP.
If your request for the medication is
on hand from your questionnaire approved by an independent EU registered
physician the prescription will be forwarded to the EU registered pharmacy for
fulfillment and dispensing.
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