Fortacin Prilocaine Lidocaine Spray
TEMPE (Topical eutectic-like mixture for premature ejaculation) now approved in Europe with the brand name of "Fortacin" 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.
Fortacin spray (also known as TEMPE or PSD502) delivers a localised application of anaesthetic and is rapidly absorbed by the non- keratinised skin of the glans penis.The anaesthetic in Fortacin 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. Lidocaine Prilocaine Plethora spray was also well tolerated by the female partners, with reports of 3.9% vulvovaginal discomfort or burning sensation caused discontinuation of treatment in 0.3% of subjects.
Studies have demonstrated that the onset of action of Fortacin spray is within minutes (<5) and that the benefit lasts for at least 2 hours.
The product will be commercialized across all 27 member states in Europe (UK, Germany, Spain, France, Italy, Netherlands, Portugal, Sweden, and so on).
Fortacin Spray has met all co-primary endpoints with the USA-FDA Phase III study:
Fortacin Spray was well tolerated and only a very low incidence of mild penile numbing (<3%) was observed.
Fortacin 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 Fortacin 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 Fortacin spray said their orgasms were 'good' or 'very good' after three months. The men had an average age of 35.
On November 19, 2013, the European Commission has granted marketing authorisation under the name ‘Prilocaine Lidocaine Plethora’, to treat primary premature ejaculation in adult men.
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