Home > Online Clinic News > Spedra Gets Final Approval in the EU

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by Robert MacKay, Thursday, June 27, 2013 | Categories: Erectile Dysfunction

Spedra, the new erectile dysfunction medication, has just been approved by the European Commission and can therefore be marketed in Europe. The medication is for men suffering from erectile dysfunction.

The approval of the marketing authorisation application (MAA) has come after a positive review by the European Medicine Agency (EMA). In specific, the positive feedback was given by the Committee for Medicinal Products for Human Use (CHMP) just a few months ago (April 2013).

Just a week ago Vivus, the pharmaceutical company that filed the application, had released the results of clinical studies that proved not only the effectiveness of Spedra, but also the ability of the medication to work within 15 minutes and sometimes in as little as 10 minutes. Significant improvement in erectile function was found after administering any of the tested doses (50 mg, 100 mg and 200 mg) of Avanafil, the active ingredient in Spedra, as the MAA specified. Vivus is now looking for partners to be able to commercialise the medication in Europe.

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