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Janssen-Cilag Submits PE Drug in EU

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Janssen-Cilag has submitted an MAA for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age. The MAA 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 6,000 subjects from 30 countries worldwide, including countries in North America, South America, Europe and Asia, and in Israel and South Africa.

The most common adverse drug reactions reported during clinical trials were headache, dizziness, nausea, diarrhea, insomnia and fatigue.

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