Fortacin Prilocaine Lidocaine Spray
PSD502 Plethora Spray APPROVED in Europe with the name of Fortacin
On November 19, 2013, the European Commission has granted marketing authorisation for the product Fortacin, 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 Fortacin spray (also known as TEMPE or PSD502), provided by the European Medicine Agency:
The efficacy of Fortacin spray:
The most common side effects which may affect up to 1 in 10 people are:
The product will be commercialized in Europe during the third quarter of 2016 with the name of Fortacin. The company owner of Fortacin commercial license in Europe, Recordati, is going to commence the production of the new 12-doses can size around November 2016, but the launch date for the rest of Europe, will be commercially available in the following months. Fortacin will be for sale across all 27 member states in Europe (UK, Germany, Spain, France, Italy, Netherlands, Portugal, Sweden, and other EU countries).
In USA, Fortacin (PSD502) new clinical trial is going to start the first quarter of the year 2016. The company who has developed Fortacin spray expects that the NDA will be filed in the first part of 2017.
TEMPE Spray helps men last longer
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:
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:
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:
Administration (FDA) will be submitted not later than the end of the first half of 2015.
Clinical data results confirm:
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."
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