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Janssen-Cilag have submitted a Marketing Authorisation Application (MAA) in Europe for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age.
Premature ejaculation is a form of male sexual dysfunction associated with marked distress and interpersonal difficulty caused by persistent or recurrent undesired ejaculation with minimal sexual stimulation before, during or shortly after penetration.
The MAA for dapoxetine was submitted under the decentralised 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 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 more than 6000 subjects from 30 countries worldwide, including countries in North America, South America, Europe and Asia, and in Israel and South Africa.
The 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. The most common adverse drug reactions reported during clinical trials were headache, dizziness, nausea, diarrhoea, insomnia and fatigue.