Janssen PE drug gets OK in Finland and Sweden

Janssen-Cilag, a subsidiary of US health care major Johnson & Johnson, has received marketing authorization in Finland and Sweden for Priligy  (dapoxetine) for the on-demand treatment of premature ejaculation.

The approvals follow the positive outcome of a decentralized marketing  authorization procedure in Sweden, Austria, Finland, Germany, Spain,  Italy and Portugal, finalized in December 2008. Finland and Sweden are  the first countries to grant marketing authorization for this compound  with approvals and licenses in the other countries expected to follow.

Dapoxetine is a unique, short-acting, selective serotonin reuptake  inhibitor (SSRI) designed to be taken one to three hours before sexual  intercourse is anticipated, and is the first oral medication to be  approved for the condition. The drug has been evaluated in five  randomized, placebo-controlled Phase III clinical trials involving more  than 6,000 men with premature ejaculation and their partners. The firm  says this is the largest and most comprehensive clinical trial program  for the condition to date.