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.