Stopping Premature Ejaculation - The Latest Treatments


 

 

PSD502, An Anesthetic Spray Cure For Premature Ejaculation

This may be a quick cure for premature ejaculation....or maybe not.

What is PSD502?

It's a new formulation of two local anesthetics, lidocaine and prilocaine, which are delivered in carefully controlled quantities by aerosol, developed by Sciele Pharma, Inc. a pharmaceutical company which focuses on developing and marketing branded prescription products to deal with cardiovascular issues, diabetes, problems in women's health, and pediatric issues.

This anesthetic spray, designed to treat premature ejaculation, sounds a bit like an anesthetic lotion for the penis which was produced in the 1970's but never really caught on. However, PSD502 is a new compound manufactured for men with premature ejaculation.

It consists of an aerosol spray with which the man can spray a numbing or desensitizing lotion onto his penis a few minutes before intercourse to reduce sensitivity to sexual stimulation. The spray contains a mixture of lidocaine and prilocaine, both well known agents in the treatment of premature ejaculation.

The results show that men who used the spray lasted up to six times longer during sex than men who had not used the spray - but were they satisfied with their orgasm? It's an important question, since men who have used condoms impregnated with local anesthetic can probably testify to the numbing effect of the local, topically applied anesthetic, but they generally seem to find that while they do not last any longer during sex, the pleasure of their orgasm is greatly reduced. This is a treatment with serious drawbacks - at least, if you see sex as something that is meant to satisfy both partners!

In this study, the results as presented by Professor Wallace Dinsmore apparently showed that PSD502 was very well received and caused few adverse effects, being well tolerated and accepted by the men who took part in the study.

We all know that many men are affected by premature ejaculation: depending on how you define the intravaginal ejaculatory latency time (IELT) which qualifies as premature ejaculation, as many as seventy five per cent of men have the problem....and every man who ejaculates too quickly knows what a problem it can be. Despite this, there is no prescription drug approved by the FDA to treat the condition; and a simple drug solution would obviously make many men's sexual experiences  - not to mention those of their partners - much more enjoyable.

The study into the effectiveness of this new drug in treating premature ejaculation was done with the help of 300 men in four European countries. The average time between penetration and ejaculation was increased to one minute in 90% of the men taking part, and to two minutes for 75% of the men taking part in the test. But these seem like very small increases - though some men would undoubtedly have benefited more - and despite the fact that the men's sexual satisfaction rating was correspondingly higher after receiving PSD502, I would be very interested to know how sex actually felt to the men concerned after they had this anesthetic applied to their penis. I believe it would not be as rewarding.

So here is the relevant data on quality of orgasm: the number of men who thought they'd had a "good" or "very good" orgasm increased from 20% to over 60% with the drug. So, it seems that the men liked it. But the result of a comparatively small scale trial like this do not really reveal much about the practical application of the system in the real world. For one thing, the conditions under which the drug was applied to the penises of the men before intercourse would no doubt have been very strictly controlled. For another, the men may have reported greater sexual satisfaction simply because they could maintain vaginal penetration for a period of time without ejaculating - that's bound to be a significant thing for a man who is accustomed to ejaculating almost immediately after penetration. 

As far as side effects were concerned, the study obfuscates by reporting that "only" 2.6% of men reported treatment-related adverse events. These included a case of penile numbness.....as opposed, presumably, to reduced sensitivity. Five men experienced mild adverse effects: one man experienced hypoesthesia (reduced sense of touch or sensation, or a partial loss of sensitivity to sensory stimuli), there were two episodes of erythema, (redness of the skin caused by capillary congestion), one report of burning, and two men lost their erections.

PSD502 is a non-ionized combination of lidocaine and prilocaine 2.5 mg in a propellant, designed to be sprayed onto a man's glans only five minutes before sexual intercourse takes place. As a result of its chemical properties the compound penetrates the surface of the penis, thus taking only five minutes before the onset of its action. Maybe the most important aspect of the study is that the drug does not only help the man to last longer - it helps his partner, who may care more about his premature ejaculation than he does.

American Urological Association 104th Annual Scientific Meeting: Abstract 1370: Presented April 28, 2009.

How to last longer in bed for men !

Latest developments around PSD502

Sciele Pharma Inc. announced in July 2009 that another double-blind, placebo-controlled study of their new compound PSD502, designed for for the treatment of premature ejaculation, has fulfilled all the measures needed to regard it as a successful treatment. These measures include standards of Intravginal Ejaculatory Latency Time and the International Index of Sexual Satisfaction.

The latest study was conducted on men from the USA, Canada and Europe. Previous research had been conducted on men from Europe, and the results reported in November 2008. Final approval for the product will be sought on the basis of the combined data.

The President and Chief Operating Officer of Sciele Pharma, Ed Schutter, reminded us that if the product gets FDA approval, it will be the first prescription treatment in the United States specifically designed to deal with the common condition of premature ejaculation.

The study was conducted as a multi-centre, double-blind, randomized, and, above all, placebo controlled investigation on 540 men with treatment for premature ejaculation offered for a 12-week period with the possibility of another voluntary phase of up to thirty sex weeks.

Both the first and second studies showed consistent results. PSD502 showed highly statistically significant improvements from the start of the study in all measures: intra-vaginal ejaculation latency time (IELT), ejaculatory control, sexual satisfaction, and partner satisfaction.

More specifically, IELT improved by a factor of six; the IPE domains for ejaculatory control and sexual satisfaction showed a five point increase; and partner satisfaction increased "considerably". All these results were highly statistically significant.

Happily, there were no more serious adverse events and overall side effects in the group of men treated with PSD502 than there were in the placebo group. There were no systemic adverse events, although a small number of men experienced a degree of numbness to the penis. This was less than 3% of the cohort.

It seems that PSD502 may be of some benefit to both men with rapid ejaculation and their partners: especially since the product can be used on an "on-demand" basis. It only takes five minutes before it becomes effective, and there must be many men who would like the product to be licensed as soon as possible! (Up to 75% of men ejaculate too rapidly for their liking or their partner's sexual satisfaction.) This drug certainly seems to have more promise than most developments in the field of premature ejaculation treatment.

However, I'd also like to remind you that not all sexual pleasure is down to your ability to develop sufficient staying power and knowing how to last longer in bed. Pleasing a woman sexually requires a degree of skill and finesse which goes well beyond the ability to make love for ages (to sustain a high IELT, in the terms of the boffins). It's worthwhile checking out this link for more information on a subset of sexual skills which are necessary for all men who (1) wish to be competent lovers and (2) have a desire to know how to please a woman in bed.

We'll let you know if or when this drug gets FDA approval! As at October 2011 there is no approval:

The Company's lead development asset PSD502, a treatment for premature ejaculation, was licensed to Shionogi Pharma Inc (formerly Sciele Pharma Inc) on a global basis in May 2009. Shionogi is today responsible for all aspects of regulatory filing and commercial development. To date the regulatory development of PSD502 has been behind expectations... given that commercialization is controlled by Shionogi, the timing and quantum of income from this agreement is uncertain...The Company has recently sought the opinion of independent regulatory experts on the work required and likelihood of achieving a regulatory approval of PSD502, particularly in the EU. As a result, the Company confirms its confidence that once filed a dossier would be approved.

Topical Treatment For Premature Ejaculation

Despite the rave reviews produced for PSD 502 (see above), the application of chemicals to the penis - however this is achieved - can be messy, indiscreet, and does rather depend on the man's partner going along with the treatment. In addition, there are problems of  anorgasmia, inability to ejaculate, and penile numbness (not to mention vaginal numbness). However, oral treatment with Viagra can be helpful when premature ejaculation develops after mild erectile dysfunction, probably because it reduces the anxiety about not getting an erection.


Antidepressant drugs as a possible treatment or cure for premature ejaculation

Premature ejaculation has always been seen as a learned behavior or conditioned response cause by rushed early sexual experiences, the conditioning heightened by anxiety. Anxiety promotes the release of adrenalin, and this makes the smooth muscle of the penis contract (a possible cause of secondary erectile dysfunction). Premature ejaculation treatment strategies developed by psychologists and sex therapists ranged from psychoanalysis to Masters & Johnson's "squeeze" technique. But these techniques need to be practiced regularly to maintain the gains from the initial treatment.

However, we know that serotonergic antidepressant drugs may cause retarded or delayed ejaculation in men who take them for depressions. Could this be significant in the treatment of premature ejaculation?

Pharmacologic Treatment

Selective serotonin reuptake inhibitors (SSRIs) have been used unofficially for some time to delay ejaculation. Because these usages are unofficial, and the drugs are not licensed for these uses, the research which would demonstrate the optimum dose has been lacking. we do know that constant use is more successful than on-demand use - a rather dramatic way of controlling rapid ejaculation, and perhaps not one that many men would be willing to take. Ongoing use of SSRIs is linked to dry mouth, nervousness, headache, drowsiness, gastrointestinal upset, diarrhea and restlessness.

So an ideal drug for premature ejaculation would be discreet, preferably oral; work rapidly, be eliminated rapidly, not accumulate in the body, and be well tolerate with few side-effects. There is no such drug at present!

Dapoxetine - The Quickest Of All Premature Ejaculation Cures?

Dapoxetine, a relatively new antidepressant, has been found to be somewhat effective for the treatment of mild cases of premature ejaculation, if you believe two major clinical trials. Dapoxetine is a reasonably short-acting SSRI or selective serotonin reuptake inhibitor (SSRI). It is not quite usual though possibly unethical for SSRIs to be used as so-called "off-label" medication for premature ejaculation.

Dapoxetine hydrochloride is a powerful inhibitor of serotonin reuptake and is a serotonin transporter inhibitor. Animal experiments have shown that intravenous Dapoxetine in varying doses has the capacity to reduce the emission and expulsion phases of ejaculation directly proportional to the dosage. Dapoxetine works - at least in rats - by increasing the pudendal motor neuron (nerve cell) reflex latency period.

Just over 1700 men tried varying doses of Dapoxetine (0, 30 mg and 60 mg) taken between 1 and 3 hours before sexual intercourse. On follow-up, the men revealed increased satisfaction with sexual intercourse, increased control of what was previously premature ejaculation, and reduced symptom severity. What's more, dapoxetine was shown to work equally well in acquired and lifelong premature ejaculation. Men who had the shortest time between penetration and ejaculation (thirty seconds or less) showed more or less a 7 fold increase in the length of time for which they could make love. Those who previously lasted between 1 and 2 minutes could now last for three times as long. Sadly, the most common side-effect is nausea.

Those with an interest in promoting Dapoxetine have shown that it is not accumulated in the body to a significant extent, and that it is rapidly eliminated. But it is a fairly major stretch to imagine this heavy duty pharmaceutical as a licensed treatment for premature ejaculation, and indeed the drug has so far not gained FDA approval. Experts doubt it will be approved by the FDA (Federal Drugs Administration) any time soon because SSRIs are associated with undesirable and sometimes troublesome side-effects after long-term application, such as mental and emotional issues, psychiatric problems, skin reactions, weight gain, lowered libido, sickness and nausea, headache, stomach upsets  and muscle weakness.

Educational Need

The majority of men who consider they have premature ejaculation also have a major tendency to worry about the problem with 58% saying they are frustrated about ejaculating too soon. According to other research, most doctors seem to think that premature ejaculation causes only minor or no distress to men who have it (a trifle odd, since presumably a lot of doctors have it and know how it affects them). About a tenth of all men have spoken to a doctor about premature ejaculation and a massive 85% of them report there was little or no improvement after consultation. In this, as in so many other ways, it seems doctors are letting their patients down - even if the only recommendation they can make is for sexual therapy.

http://cme.medscape.com/viewarticle/520278

 


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