Vivus' erectile dysfunction (ED) drug Stendra has received approval from the US Food and Drug Administration, providing competition to ED drugs such as Pfizer's Viagra.
Stendra has been given the green light following three Phase III studies, which demonstrated that of the 1,267 patients tested over 12 weeks, those who received Stendra experienced significant improvement in endpoints including ED, vaginal penetration and successful intercourse.
Stendra is a phosphodiesterase type 5 (PDE5) inhibitor, much like the three drugs it will come up against in the ED treatment market including Pfizer's market-leading Viagra, Eli Lilly's Cialis and Bayer's Levitra.
All three rival drugs have already started to garner market share and will be around for some time, with Viagra, Cialis and Levitra enjoying patent protection until 2019, 2016 and 2018 respectively.
Stendra could, however, be boosted by results from the Phase III studies, which suggested that Stendra achieved a far earlier time of onset than other medications, with some patients reporting success as early as 15 minutes.
Vivus president Peter Tam heralded the drug's approval, stating that patients and physicians continue to report dissatisfaction with current ED treatments.
"We believe that the PDE5 selectivity and absorption profile of Stendra make it an important new treatment option for many men with erectile dysfunction," added Tam.
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