PRILIGY® (dapoxetine) and Premature ejaculation in Men.

Dapoxetine hydrochloride made by Ortho-McNeil Pharmaceutical.

In 2007, Janssen-Cilag companies in Europe have submitted a Marketing Authorisation Application (MAA) for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age.

Dr. Jon Pryor, head researcher, University of Minnesota, said that Dapoxetine lengthened ejaculation time and also gave patients more control over ejaculation.

What is Premature Ejaculation?

In lay terms it means ‘coming too quickly’ (for a man). The man ejaculates sooner than he or his partner would like. It is common for this to happen now and again. It is seen as a problem for many men and some of their partners if this happens regularly. It is the most common male sexual dysfuntion – estimated to affect about 20% of males in the USA aged 18-59.
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The problem is thought to be psychological. However, it can also be biological.

Premature ejaculation has two classifications:

Primary Premature Ejaculation
The man has experienced premature ejaculation throughout his sexually active life.

Secondary Premature Ejaculation
The condition has developed after the man used to have satisfying sex without ejaculatory problems.

Premature ejaculation is a form of male sexual dysfunction associated with marked distress and interpersonal difficulty caused by persistent or recurrent undesired ejaculation with minimal sexual stimulation before, during or shortly after penetration.

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The MAA for dapoxetine was submitted under the decentralised procedure, in which Sweden will act as the Reference Member State and Austria, Finland, Germany, Italy, Portugal and Spain will act as the Concerned Member States for the application. Regulatory submissions in other regions of the world are expected to follow.

Dapoxetine is the first oral pharmacologic agent developed specifically for the treatment of men with PE. The safety and efficacy of dapoxetine for the treatment of men with PE were studied in five, double-blind, placebo- controlled, Phase III clinical trials involving over 6,000 subjects from 30 countries worldwide, including countries in North America, South America, Europe and Asia, and in Israel and South Africa.

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