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Priligy(TM) (Dapoxetine) Receives First Regulatory Approvals for the Treatment of Premature Ejaculation (PE) in Finland and Sweden
Date:2/10/2009

BEERSE, Belgium, February 10 /PRNewswire-FirstCall/ -- Janssen-Cilag EMEA, a division of Janssen Pharmaceutica N. V., announced today that Priligy(TM) (dapoxetine) has received marketing authorisation in Finland and Sweden for the on-demand treatment of premature ejaculation (PE) in men 18-64 years of age. These approvals follow the positive outcome of a decentralised marketing authorisation procedure in seven European Union countries: Sweden, Austria, Finland, Germany, Spain, Italy and Portugal. The procedure was finalised in December 2008, and Finland and Sweden are the first countries worldwide to grant marketing authorisation for this compound. National approvals and licenses in the other five European countries are expected to follow. Dapoxetine is not approved for marketing in the United States.

Dapoxetine is a drug specifically developed for the on-demand treatment of PE and is the first oral medication (tablet) to be approved for this condition. Dapoxetine has been extensively evaluated in five randomised, 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 programme to date for a drug therapy to treat PE. Dapoxetine 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.

Dapoxetine will be marketed by Janssen-Cilag, marking another significant advance in the company's commitment to developing innovative, high quality treatments for unmet medical needs.

Premature Ejaculation

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 wit
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SOURCE Janssen-Cilag
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