Spedra (Vivus Inc.) receives EU approval as a treatment for Erectile Dysfunction
Vivus, Inc. announced that the European Commission (EC) has adopted the implementing decision granting marketing authorization for Spedra (avanafil) for the treatment of Erectile Dysfunction (ED) in the European Union (EU).
In the TA-501 study, ED patients achieved statistically significant improvement over placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse as early as 10 minutes following administration for the 200 mg dose and 12 minutes following administration for the 100 mg dose. Spedra,a PDE5 inhibitor, is the first new chemical entity (NCE) approved for ED in over a decade. The global market for ED therapies was approximately $5.5 billion in 2012.
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