Dr. Mike Wyllie, one of the scientists who invented "Viagra", has abetted an effective cure for premature ejaculation. Tempe Spray is expected to be launched in the pharmaceutical market by next year, and according to American and European re-searchers, men could almost last six-times longer with the help of this easy-to-apply sex spray.
TEMPE (Topical eutectic-like mixture for premature ejaculation) is a rapidly acting spray formulation of two local anesthetics (three metered doses of the spray applied to the glans of the penis providing 22.5mg lidocaine and 7.5mg prilocaine) for the treatment of premature ejaculation (PE) and established by Plethora Solutions Ltd (London). It is applied on to the tip of the penis for few minutes, before sexual encounter and does not require condom use.
Tempe spray delivers a localized application of anesthetic and is rapidly absorbed by the non- keratinized skin of the glans penis. The anesthetic in TEMPE spray doesn't spear intact or fully keratinized skin and can be easily wiped off with a damp cloth in order to minimize transference to the sexual-partner. TEMPE spray was also well accepted by the female partners, with no information of numbness of the vagina.
Studies have revealed that the on-set action of TEMPE spray is within minutes and that the benefit lasts for at least 2 hours.
TEMPE Spray has met all the co-primary end-points with the USA-FDA Phase III study:
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 among Tempe Spray & 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 was a 2.5-point difference between Tempe Spray and placebo, whereas a 2 point difference is considered clinically substantial.
Tempe Spray was well abided and only a very low incidence of mild penile numbing was observed.TEMPE Spray Phase III recruitment program in the USA is now completed for the treatment of premature ejaculation.Tempe Spray would be the first prescribed treatment in the United States for premature ejaculation, upon FDA approval.
In Europe, a phase III study data show that average men who got the spray lasted almost 6.3 times longer than those who got the placebo.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 3 months. The men had an average age of 35.
Side effects during the FDA’s clinical trial included low incidence of mild penile numbing, while one patient stated temporary penile numbing in the European Phase III trial. The CHMP has already acclaimed Tempe’s approval. FDA approval is expected to be out by the first half of 2014.
What is Tempe?
Tempe spray delivers a localized application of anesthetic and is rapidly absorbed by the non- keratinized skin of the glans penis. The anesthetic in TEMPE spray doesn't spear intact or fully keratinized skin and can be easily wiped off with a damp cloth in order to minimize transference to the sexual-partner. TEMPE spray was also well accepted by the female partners, with no information of numbness of the vagina.
Studies have revealed that the on-set action of TEMPE spray is within minutes and that the benefit lasts for at least 2 hours.
TEMPE Spray has met all the co-primary end-points with the USA-FDA Phase III study:
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 among Tempe Spray & 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 was a 2.5-point difference between Tempe Spray and placebo, whereas a 2 point difference is considered clinically substantial.
Tempe Spray was well abided and only a very low incidence of mild penile numbing was observed.TEMPE Spray Phase III recruitment program in the USA is now completed for the treatment of premature ejaculation.Tempe Spray would be the first prescribed treatment in the United States for premature ejaculation, upon FDA approval.
In Europe, a phase III study data show that average men who got the spray lasted almost 6.3 times longer than those who got the placebo.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 3 months. The men had an average age of 35.
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