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news.Janssen-Cilag companies in Europe have submitted a marketing authorization application for dapoxetine, a treatment for premature ejaculation in men 18-64 years of age.
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The MAA for dapoxetine was submitted under the decentralized procedure, in which Sweden will act as the reference member state and Austria, Finland, Germany, Italy, Portugal and Spain will act as the concerned member states for the application. Regulatory submissions in other regions of the world are expected to follow.
Dapoxetine is the first oral pharmacologic agent developed specifically for the treatment of men with premature ejaculation (PE). The safety and efficacy of dapoxetine for the treatment of men with PE were studied in five, double-blind, placebo- controlled, Phase III clinical trials involving over 6,000 subjects from 30 countries worldwide, including countries in North America, South America, Europe and Asia, and in Israel and South Africa.
Results of all randomised studies were consistent, and improvements included both increases in average intravaginal ejaculatory latency time (IELT) and improved patient-reported outcomes of increased control over ejaculation and reduced personal distress related to ejaculation.