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Viagra Scientist Takes Aim at Premature Ejaculation Treatment

A topical drug called Tempe, for treatment of premature ejaculation is available by prescription in Europe and the UK, but is not yet available in the US.

 

In the Diagnostic Statistical Manual of Mental Disorders (DSM IV), premature ejaculation (PE) is defined as a “persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before a person wishes.”

However, the first contemporary, evidence-based definition of (PE) wasn’t developed until 2007 by an international expert panel of the International Society for Sexual Medicine. They concluded that PE has three components: short time from penetration to ejaculation, inability to delay ejaculation, and negative personal consequences because of it.

Premature ejaculation is considered the most common sexual complaint of men, and estimates of its prevalence range from 4% to 39%. Across all age groups, prevalence of PE is estimated at 30%. In general, when ejaculation occurs within less than one minute after penetration, it is considered premature. However, there are different cultural and religious factors throughout the world that influence exactly what is considered normal.

What Causes Premature Ejaculation?

One of the most common causes of PE is sexual performance anxiety. Other common causes of PE include relationship problems, psychological problems, and erectile dysfunction. Sometimes it is caused by prostatitis (enlargement of the prostate gland), or by detoxification from prescribed or illicit drugs. Until recently, curing PE meant identifying and treating any underlying medical or psychological cause, and that’s not always easy or straightforward.

Current Options for Treating Premature Ejaculation

Current options for treating premature ejaculation include things like practicing relaxation techniques or distraction in order to delay ejaculation. Some men have found improvement by cutting back on or quitting use of alcohol, tobacco, or illegal drugs. Relaxation techniques involve a man’s identifying and controlling the sensations that lead to ejaculation and communicating with his partner about slowing or stopping the stimulation that causes it. Some men find relief by using a condom to reduce sensation, or by trying different positions.

There are doctors who will prescribe antidepressant medications off-label due to their well-known side effect of inhibiting orgasm, which delays ejaculation. Clomipramine and Tramadol are two drugs that are prescribed off-label for treating PE. Medications like lidocaine can be applied to the penis to reduce sensation before sexual activity, but this can cause problems by reducing the partner’s sensation as well. One way and another, today’s treatments for PE leave a lot to be desired.

That could change in the next few years, however. Dr. Mike Wyllie, who was involved in Pfizer’s development of the blockbuster erectile dysfunction (ED) drug Viagra in the 1990s, is now trying to get approval for a new prescription spray drug developed by the British biotech company Plethora Solutions.

Plethora’s New Product

Tempe isn’t yet available in the United States.

 

Plethora has developed a spray called Tempe that has been judged as safe and effective by the European Medicines Agency. It is expected to be available in Europe by prescription in 2015. Tempe contains low doses of two anesthetics and is used on demand. After applying the spray, effects are noticeable in about five minutes and last for about two hours. One of the advantages of Tempe is that there is minimal partner transfer, so men do not have to wear a condom to protect the partner from absorbing the product and experiencing diminished sensation.

A pocket-sized spray canister is expected to last for a year. In Europe, hopes are that it will eventually be judged inexpensive enough to be covered by national health plans like the UK’s National Health Service. It will be commercialized across all 27 member states in Europe in mid- to late-2014.

Tempe Clinical Trials in the US

In the United States, research was presented to the 2010 American Urological Association Meeting showing that 536 men with premature ejaculation and treated with Tempe spray five minutes before intercourse maintained erections an average of 5.5 times longer than men who used a placebo spray. The study took place in 70 locations in the USA, Canada, and Europe over a three month period. The drug was used 23,000 times during the study period. The side effect of burning sensation on the part of the partner was only recorded 5% of the time.

Phase III trial data have been submitted to the Food and Drug Administration (FDA), with results meeting the goals of FDA Phase III trials. The drug has still not been approved in the United States, however, as of late 2018.

Priligy Already Available in Europe

An oral drug called Priligy is already available in Europe, and marks the first serotonin-specific reuptake inhibitor (SSRI) designed specifically for use by men with premature ejaculation. The generic name for the drug in Priligy is dapoxetine, which was initially studied as a possible SSRI antidepressant. Early research showed that it was unsuitable for use as an antidepressant, since it is absorbed and eliminated rapidly. However, its fast-acting nature and swift elimination make it well-suited for treating PE. It is sold in several countries in Europe and Asia, and is also sold in Mexico.

In the US, the drug is still in phase III development. Researchers have concluded that the drug is safe and well-tolerated as an on-demand treatment for premature ejaculation, and have pointed out that studies of off-label antidepressant use for treating PE have been hampered by small study populations, lack of proper controls, and inconsistent reporting. Priligy currently has the largest database for effectiveness and safety for men with PE of any other SSRI-class drug. However, it is unclear if or when it will be granted FDA approval.

Before development of Viagra and other drugs in its class, ED was often thought of as “all in the mind,” but the introduction of Viagra and its competitors has largely changed the conversation about ED. Treatment options for premature ejaculation are very limited right now, though Dr. Wyllie and Plethora Solutions hope that will change later on this year when Tempe goes on sale in Europe. If you suffer from PE, you’ll want to keep an eye on the approval cycle of Tempe in the US, because it could provide an effective new treatment option.

At, we’re committed to helping people enjoy a satisfying sex life. We dispense prescription medications including Viagra, Levitra, Cialis, and Staxyn using US-licensed pharmacists, and ship quickly and discreetly using trusted shipping providers like FedEx. eDrugstore.com is also HIPAA-compliant and is thoroughly committed to providing great customer service and using only the most effective online security measures.

Don Amerman has spent more than three decades in the business of writing and editing. During the last 15 years, his focus has been on freelance writing. For almost all of his writing, He has done all of his own research, both online and off, including telephone and face-to-face interviews where possible. Don Amerman on Google+