What Is TEMPE Spray?

TEMPE (Topical eutectic-like mixture for premature ejaculation) is a rapidly acting spray formulation of two local anaesthetics (three metered doses of the spray applied to the glans of the penis delivering 22.5mg lidocaine and 7.5mg prilocaine) for the treatment of premature ejaculation (PE) and developed by Plethora Solutions Ltd, London. It is spritzed onto the tip of the penis few minutes (<5 minutes) before sex and does not require condom use.

Tempe spray delivers a localised application of anaesthetic and is rapidly absorbed by the non- keratinised skin of the glans penis.The anaesthetics 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. TEMPE spray was also well tolerated by the female partners, with no reports of numbness of the vagina.

Studies have demonstrated that the onset of action of TEMPE spray is within minutes (<5) and that the benefit lasts for at least 2 hours.

This product is not yet available on the market.

TEMPE Spray has met all co-primary endpoints 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 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 Phase III recruitment programme in the USA is now completed for the treatment of premature ejaculation.

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

In Europe, a phase III study data show on average, men who got the spray lasted 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 three months. The men had an average age of 35.

"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."