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Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today announced that the European Commission endorsed the positive opinion adopted by the Committee for Human Medicinal Products (CHMP) on October 18, 2011 for Priligy™ (dapoxetine) 30 mg and 60 mg doses. Pending national approvals, the marketing authorization for the Priligy doses can be granted in the European Union Member States where the drug has not yet been approved, and also in Norway and Iceland. The indication for Priligy approved by the EC is the on-demand treatment of premature ejaculation in men between the ages of 18 and 64.
“We are pleased with the decision of the European Commission,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “This decision will make Priligy, the only approved medication for premature ejaculation, available to a wider market in the EU.”
About Premature Ejaculation
Premature ejaculation (PE) is a distressing sexual dysfunction that can be present from the first sexual encounter or can develop later in life. The condition consists of three major components: a short time to ejaculation, lack of ejaculatory control, and negative personal impact, including distress related to rapid ejaculation. A combination of physiological and psychological factors is believed to influence the mechanism of ejaculation. Research suggests serotonin plays a central role in the timing of ejaculation.
Priligy (dapoxetine) is a unique, short-acting, selective serotonin reuptake inhibitor (SSRI) designed to be taken only when needed – one to three hours before sexual intercourse is anticipated – rather than every day. The drug is specifically developed for the on-demand treatment of PE and was extensively evaluated in 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 the first oral medication (tablet) to be approved for this condition in a growing number of countries around the world. Priligy is marketed by Janssen-Cilag, a division of Johnson & Johnson.