Premature Ejaculation - New Drug

PRILIGY®, dapoxetine hydrochloridrate, is a potent and selective inhibitor of serotonine re-uptake (SSRIs) that is indicated for the treatment of premature ejaculation (PE). Althought they are not indicated for the treatment of PE, conventional SSRIs antidepressants are commonly used for the treatment of this condition. Janssen-Cilag EMEA, a division of Janssen Pharmaceutica N.V., announced that PRILIGY® 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. Actually in Italy PRILIGY® is distribuited by the Menarini Group. 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 (SSRIs) designed to be taken only when needed, that is 1-3 hours before sexual intercourse is anticipated, rather than every day.