Priligy (Dapoxetine) Received Approvals in Sweden and Finland

Priligy is the first oral prescription drug approved for the treatment of Premature Ejaculation (PE). A Major milestone for PE patients around the world.

BEERSE, Belgium, Janssen-Cilag EMEA, a division of Janssen Pharmaceutica N. V., a Johnson & Johnson company announced today that Priligy ^(TM) ( dapoxetine ) has received marketing approval in Finland and Sweden for the treatment of PE in men aged 18-64. These approvals follow the positive outcome of the marketing authorization procedure in seven European countries: Sweden, Austria, Finland, Germany, Spain, Italy and Portugal. The procedure was finalized recently, and Finland and Sweden are the first countries worldwide to grant approval for this compound. National approvals and licenses in the other five European countries are expected to follow soon. Priligy is not approved for marketing in the United States. It is expected that with the approval of Priligy in Europe the US FDA will have to review its file again and consider its approval. Approval in Europe without an approval in the US for such a drug could become an issue and force illegal importation of Priligy into the US.

Priligy is a drug specifically developed for the treatment of PE and is the first oral medication (tablet) to be approved for this condition. Priligy has been extensively evaluated in a very large clinical program that included five randomized, placebo-controlled Phase III clinical trials involving more than 6,000 men with PE and their partners. This is the largest and most comprehensive clinical trial program to date for a drug therapy to treat PE. Priligy is a unique, short-acting, selective serotonin reuptake inhibitor ( SSRI ) designed to be taken only when needed, that is 1-3 hours before sexual intercourse is anticipated, rather than every day.

PE is a distressing sexual dysfunction that can be present from the first sexual encounter or can develop later in life. Depending on the methodology and criteria used to evaluate the prevalence of PE in studies, the reported proportion of men affected with this condition at some point in their lives has ranged from 4-30%. Experts in PE from the International Society of Sexual Medicine (ISSM) define the condition as consisting of three major components: a short time to ejaculation (prior to or within about one minute), lack of ejaculatory control and negative personal impact or distress related to ejaculation. Unlike erectile dysfunction (ED), which tends to affect older men, PE has similar prevalence across all age groups. In fact, more men are believed to experience PE than ED.

A combination of physiological and psychological factors are believed to influence the mechanism of ejaculation. Men with PE appear to go through the same process of ejaculation as other men, but it happens more quickly and with a reduced feeling of control. Research suggests serotonin plays a central role in the timing of ejaculation.

After approval in a specific country, Priligy ( dapoxetine ) will only be available by prescription from a healthcare professional. Therefore, a patient that will be interested to buy Priligy will have to do the same as he does for any other prescription drug.

The product is expected to be made available for purchase in licensed pharmacies in the countries where approved around April 2009, after all local regulatory requirements related to packaging and pricing are finalized. Janssen-Cilag will provide official confirmation of the exact date of product availability in each individual country. Applications for marketing authorization in other countries are under review. Priligy cannot be bought as of now.

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