PSD502 Prilocaine Lidocaine Spray
What Is TEMPE Spray?
Clinical Trials Results
Side-Effects
Can I Buy TEMPE Spray?
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PSD502 Plethora Spray APPROVED in Europe
It expects to file USA marketing approval next year

tempe spray

On November 19, 2013, the European Commission has granted marketing authorisation for the product under the name ‘Prilocaine Lidocaine Plethora’, a topical eutectic-like mixture spray to treat primary premature ejaculation in adult men.

Let's summarized some important information about the efficacy and most common side effects of "Lidocaine Prilocaine Plethora" spray (also known as TEMPE or PSD502), provided by the European Medicine Agency:

The efficacy of "Lidocaine Prilocaine Plethora" spray:

  • During the 3 months of the treatment phase, the subjects treated with "Lidocaine Prilocaine Plethora" spray increased their time in minutes from 0.58 to 3.17.
  • 85.2% of the subjects achieved more than 1 minute.
  • 66.2% of them achieved more than 2 minutes.

The most common side effects which may affect up to 1 in 10 people are:

  • 4.5% of genital hypoaesthesia (a reduced sensation) and 4.4% erectile dysfunction. These adverse reactions caused discontinuation of treatment in 0.2% and 0.5% of patients, respectively.
  • 3.9% vulvovaginal burning sensation in female partners and 1.0% genital hypoaesthesia. Vulvovaginal discomfort or burning sensation caused discontinuation of treatment in 0.3% of female partners.

The product will be commercialized in the mid-to late-2014, across all 27 member states in Europe (UK, Germany, Spain, France, Italy, Netherlands, Portugal, Sweden, and so on).

The company who has developed "Lidocaine Prilocaine Plethora" spray expects to file US-FDA marketing authorization in the first quarter of 2016.


TEMPE Spray helps men last longer
Men last 6 times longer with TEMPE spray used five minutes before sex

According to a study in the 2009 April issue of BJU International, men with premature ejaculation (PE) who used Tempe Spray five minutes before intercourse were able to delay their orgasm 6 times longer. The time from penetration to ejaculation increased from an average of 0.6 minutes to 3.8 minutes.



FDA USA Phase III clinical results confirm:

Tempe Spray has met all co-primary endpoints:

  • The intra-vaginal ejaculation latency time (IELT) was increased at least six-fold with Tempe Spray when compared to baseline.
  • There was a 5 point difference between Tempe Spray and placebo in the Index of Premature Ejaculation (IPE) domains for ejaculatory control and sexual satisfaction, where a 2 point difference is considered clinically significant.
  • IPE domain for Distress was a 2.5-point difference between Tempe Spray and placebo, where a 2 point difference is considered clinically significant.
  • And partner satisfaction, as a secondary endpoint, was also found considerably greater with Tempe Spray than placebo.

Tempe Spray was well tolerated and only a very low incidence of mild penile numbing (<3%) was observed.


Tempe Spray would be the first prescription treatment in the United States for premature ejaculation, upon FDA approval.


Similar positive results confirmed in European Phase III study:

  • Both Patient and Partner Satisfaction Increased Significantly
  • 86 percent of Patients Rated the Treatment as Positive
  • Well Tolerated and Devoid of Systemic Side Effects

The number of patients in the Tempe Spray group who rated the quality of their orgasm as good or very good increased from 20 percent at baseline to 62 percent after treatment. In comparison, the number of placebo-treated patients with this rating decreased from 21 percent to 19 percent.

The Principal Investigator in the study, Prof Wallace Dinsmore, Royal Victoria Hospital, Belfast commented:

  • “These results are as impressive as those observed with the phosphodiesterase inhibitors (PDEi) in erectile dysfunction at an equivalent stage of development. The positive impact of Tempe Spray on both patients and their partners could save many relationships”.
A possible New Drug Application (NDA) in the USA with the Food and Drug
Administration (FDA) will be submitted not later than the end of the first half of 2015.


Clinical data results confirm:

  • The product is applied locally when needed (often referred to as “on demand” therapy)
  • Rapid onset of action is within minutes (<5) and that the benefit will last for at least 2 hours
  • Is well-tolerated: minimal partner transfer eliminating the need to use a condom for protection from the product and the potential for the dose to be self-titrated or adjusted under physician direction
  • No unexpected adverse events; negligible systemic toxicity

Patients with premature ejaculation who used a TEMPE spray were able to delay ejaculation 6 times longer according to a study in the 2009 April issue of BJU International.

The spray is called TEMPE (Topical eutectic-like mixture for premature ejaculation) by manufacturer Plethora Solutions Ltd. London. Tempe spray is a metered-dose aerosol containing a combination of the well known local anaesthetics lidocaine and prilocaine and the anaesthetic in TEMPE spray doesn't penetrate intact or fully keratinised skin and can be easily wiped off with a damp cloth in order to minimise transference to the sexual partner. It is not yet available on the market.

Two hundred men diagnosed with premature ejaculation using Tempe Spray from 31 centres in the UK, Czech Republic, Hungary and Poland were able to last 6.3 times longer versus placebo group.

Results of a phase III clinical trials with 300 heterosexual men with premature ejaculation shows that 90% of the men in the treatment with TEMPE spray were able to delay ejaculation for more than one minute following vaginal penetration, 74% of men last more than two minutes before ejaculation and 62% of men with TEMPE spray said their orgasms were 'good' or 'very good' after three months. The men had an average age of 35.

Before the test and without any therapy they normally ejaculated an average of 0.6 minute after vaginal penetration.


"The men who were prescribed the TEMPE spray, which delivers a combination of lidocaine and prilocaine, managed to delay ejaculation by just under an extra four minutes after using the product" reports Professor Wallace Dinsmore from the Royal Victoria Hospital, Belfast.

"Meanwhile the control group, who were prescribed a placebo (dummy) spray, increased their penetration to ejaculation time by just over 40 seconds.


No adverse effects were found during patient safety checks, which included vital signs, physical findings, electrocardiograms, haematology, biochemistry and urine analysis.


"The encouraging data from this phase III study suggests that TEMPE has the potential to offer a convenient, novel treatment for men with premature ejaculation and might be useful as a first-line treatment for the condition."


 


Tempe Spray Frequently Asked Questions


 

What Is TEMPE Spray?
Clinical Trials Results
Side-Effects
Can I Buy TEMPE Spray?
Resources


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You should always consult a doctor with any questions you may have regarding a medical condition.

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